Highly Drug-resistant Focal EpilepsyPhase 2NCT02625090
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
A Phase 2 study testing UCB0942 in people with Highly Drug-resistant Focal Epilepsy, run by UCB Biopharma SRL at 15 sites in 6 countries.
Trial summary
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Highly Drug-resistant Focal Epilepsy
- What is being tested?
- UCB0942
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 3 Dec 2015to 24 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
- Subject must have completed Visit 13 (V13) of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
- In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
- In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
- No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
- Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods
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- Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom)Exclusion Criteria:
- Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
- Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry
- Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
- Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females
- Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
- In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
- Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073
- Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For enrolled subjects with a baseline result
- ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening (ie, the value is
- ULN but <=2xULN at the EV [V2] of EP0073), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor
Who cannot join
None listed.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Spain5 sites
Ep0073 502
Barcelona
Ep0073 505
L'Hospitalet de Llobregat
Ep0073 506
Madrid
Ep0073 501
Seville
Ep0073 503
Valencia
About this study
Official title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.
Read the detailed description
For those subjects who benefit substantially from UCB0942 in the multicenter, randomized, double-blind, placebo-controlled, parallel group study EP0069, the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety, tolerability and efficacy of long-term study treatment.
- Conditions
- Highly Drug-resistant Focal Epilepsy
- Being tested
- UCB0942
- Keywords
- Drug-resistance, focal epilepsy, partial-onset seizures
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0942Drug
- Active Substance: UCB0942
- Pharmaceutical form: Film-coated tablet
- Concentration: 25 mg, 100 mg or 200 mg
- Route of Administration: oral
| Study group | Role | What they receive |
|---|---|---|
| UCB0942 | Experimental | UCB0942 400 mg bid or a tapered UCB0942 dose of 200 mg bid.
The Investigator will be allowed to increase or decrease the dose of UCB0942 to optimize tolerability and seizure control for each subject. Increases or decreases to the dose of UCB0942 should be made in steps not exceeding 200 mg/day per week; an exception is Taper Week 1 where a step of 800 mg/day to 500 mg/day is allowed. A faster decrease of the dose than 200 mg/day per week is allowed when it is clinically appropriate in the Investigator's medical judgment. Daily UCB0942 doses during this study may be 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid); intermediate doses will not be allowed except for tapering and titration unless agreed by the UCB Study Physician or PRA Medical Monitor. The dose of UCB0942 must always be administered as bid morning and evening doses, approximately 12 hours apart. Receives: Drug: UCB0942 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) From the Beginning at Entry Visit (EV) of the Evaluation Period to End of Safety Follow-Up Visit During the EP0073 Study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Percentage of participants experiencing at least one treatment-emergent adverse event (reported by the participant and/or caregiver or observed by the Investigator or inpatient staff) are reported.
Measured: From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)
75% Responder Rate by 3-month Interval (Month 0 to 3) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month 0-3)
75% Responder Rate by 3-month Interval (Month >3-6) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >3-6)
75% Responder Rate by 3-month Interval (Month >6-9) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >6-9)
75% Responder Rate by 3-month Interval (Month >9-12) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >9-12)
75% Responder Rate by 3-month Interval (Month >12-15) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >12-15)
75% Responder Rate by 3-month Interval (Month >15-18) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >15-18)
75% Responder Rate by 3-month Interval (Month >18-21) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >18-21)
75% Responder Rate by 3-month Interval (Month >21-24) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >21-24)
75% Responder Rate by 3-month Interval (Month >24-27) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >24-27)
75% Responder Rate by 3-month Interval (Month >27-30) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >27-30)
75% Responder Rate by 3-month Interval (Month >30-33) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >30-33)
75% Responder Rate by 3-month Interval (Month >33-36) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >33-36)
75% Responder Rate by 3-month Interval (Month >36-39) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >36-39)
75% Responder Rate by 3-month Interval (Month >39-42) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >39-42)
75% Responder Rate by 3-month Interval (Month >42-45) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >42-45)
75% Responder Rate by 3-month Interval (Month >45-48) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >45-48)
75% Responder Rate by 3-month Interval (Month >48-51) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >48-51)
75% Responder Rate by 3-month Interval (Month >51-54) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >51-54)
75% Responder Rate by 3-month Interval (Month >54-57) Over the Evaluation Period
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
Measured: Over 3-month interval over the Evaluation Period (Month >54-57)
Secondary outcomes (7)
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Median partial-onset seizure frequency per 28 days by 3-month intervals over the Evaluation Period of the EP0073 study was reported.
Measured: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Median partial-onset seizure frequency per 28 days by seizure type (Type IA1, Type IB, Type IC) by 3-month intervals over the Evaluation Period of the EP0073 study was reported. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981.
Measured: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Percent change from Baseline in seizure frequency for observable focal-onset seizures (Type IA1, IB, and IC) to the corresponding interval was calculated using the following formula: change from Baseline in the 28 day adjusted seizure frequency/28 day adjusted seizure frequency during the EP0069 2- week Prospective Outpatient Baseline Period × 100. The numerator is calculated by subtracting the 28-day adjusted seizure frequency during the Period of interest from the 28-day adjusted seizure frequency during the EP0069 2-week prospective outpatient Baseline Period. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981.
Measured: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period, Relative to Baseline (of EP0069)
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study
A 50% responder was defined as a participant with a ≥50% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 50% responders during the period/number of participants during the period × 100.
Measured: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period
The number of seizure-free days is defined as the total number of days within an analysis Period or time interval for which no seizures were reported. The percentage of seizure-free days is to be computed as 100 times the number of seizure-free days divided by the number of days for which daily diary data was available in the specified analysis Period. Days without the corresponding daily diary data (ie, "Not Done" is ticked) are not used in these computations.
Measured: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Seizure-free Rate Over the Evaluation Period
Participants were considered seizure free for a given Period or time interval if the participant, completes the Period or time interval, reports no seizures during the Period, and has no more than 10% of days in the Period for which seizure data is not available (ie, "Not Done" is reported on the Seizure Count CRF). The seizure freedom rate (%) for a specific time Period was calculated using the following formula: Count of seizure free participants during the Period/ Number of participants during the Period × 100.
Measured: Over the Evaluation Period (up to 5 years)
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073
The QOLIE-31-P includes 30 items grouped into 7 multi-item subscales (seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive functioning, medication effects, and social function) and a health status item. Individual responses for the 30 subscale items are rescaled to 0 to 100 with higher scores reflecting better functioning. Each subscale score is then calculated by summing rescaled responses for that subscale and dividing by number of items with non-missing response. Responses for health status item are multiple of 10 ranging from 0 to 100 with a higher score corresponding to better health status. The QOLIE-31-P total score was calculated as weighted sum of the subscale scores which ranges from 0 to 100 with higher score reflecting better functioning.
Measured: Month 3, 7, 13, 19, 25, 31, 37, 43, 49, early discontinuation visit (EDV) (up to Month 58), Relative to Baseline (of EP0069)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start3 Dec 2015
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Why it stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Highly Drug-resistant Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625090
- Sponsor's protocol ID
- EP0073
- Other IDs
- 2015-001268-20, 2015
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2015
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT02625090
- Acronym / sponsor ID
- EP0073
- Conditions
- Highly Drug-resistant Focal Epilepsy
- Keywords
- Drug-resistance, focal epilepsy, partial-onset seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
- Enrolment
- 42 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 31 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.
Detailed description
For those subjects who benefit substantially from UCB0942 in the multicenter, randomized, double-blind, placebo-controlled, parallel group study EP0069, the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety, tolerability and efficacy of long-term study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCB0942 | Experimental | Drug: UCB0942UCB0942 400 mg bid or a tapered UCB0942 dose of 200 mg bid. The Investigator will be allowed to increase or decrease the dose of UCB0942 to optimize tolerability and seizure control for each subject. Increases or decreases to the dose of UCB0942 should be made in steps not exceeding 200 mg/day per week; an exception is Taper Week 1 where a step of 800 mg/day to 500 mg/day is allowed. A faster decrease of the dose than 200 mg/day per week is allowed when it is clinically appropriate in the Investigator's medical judgment. Daily UCB0942 doses during this study may be 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid); intermediate doses will not be allowed except for tapering and titration unless agreed by the UCB Study Physician or PRA Medical Monitor. The dose of UCB0942 must always be administered as bid morning and evening doses, approximately 12 hours apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
- Subject must have completed Visit 13 (V13) of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
- In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
- In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
- No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB0942* Active Substance: UCB0942 * Pharmaceutical form: Film-coated tablet * Concentration: 25 mg, 100 mg or 200 mg * Route of Administration: oral | Drug | UCB0942 |
Primary outcome
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) From the Beginning at Entry Visit (EV) of the Evaluation Period to End of Safety Follow-Up Visit During the EP0073 Study
Time frame: From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Percentage of participants experiencing at least one treatment-emergent adverse event (reported by the participant and/or caregiver or observed by the Investigator or inpatient staff) are reported.
75% Responder Rate by 3-month Interval (Month 0 to 3) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month 0-3)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >3-6) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >3-6)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >6-9) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >6-9)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >9-12) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >9-12)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >12-15) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >12-15)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >15-18) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >15-18)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >18-21) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >18-21)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >21-24) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >21-24)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >24-27) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >24-27)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >27-30) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >27-30)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >30-33) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >30-33)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >33-36) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >33-36)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >36-39) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >36-39)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >39-42) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >39-42)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >42-45) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >42-45)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >45-48) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >45-48)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >48-51) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >48-51)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >51-54) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >51-54)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
75% Responder Rate by 3-month Interval (Month >54-57) Over the Evaluation Period
Time frame: Over 3-month interval over the Evaluation Period (Month >54-57)
A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.
7 secondary outcomes
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Time frame: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Time frame: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Time frame: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period, Relative to Baseline (of EP0069)
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Time frame: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period
Time frame: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period
Seizure-free Rate Over the Evaluation Period
Time frame: Over the Evaluation Period (up to 5 years)
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073
Time frame: Month 3, 7, 13, 19, 25, 31, 37, 43, 49, early discontinuation visit (EDV) (up to Month 58), Relative to Baseline (of EP0069)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UCB0942 in people with Highly Drug-resistant Focal Epilepsy, run by UCB Biopharma SRL at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Belgium, Germany, Hungary, Bulgaria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) From the Beginning at Entry Visit (EV) of the Evaluation Period to End of Safety Follow-Up Visit During the EP0073 Study (time frame: From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.