Partial Seizures With or Without Secondary GeneralizationPhase 3NCT03685630
A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
A Phase 3 study testing Brivaracetam in people with Partial Seizures With or Without Secondary Generalization and Epilepsy, run by UCB Biopharma S.P.R.L. at 9 sites in Japan.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects >=16 years of age with partial seizures with or without secondary… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Partial Seizures With or Without Secondary Generalization, Epilepsy
- What is being tested?
- Brivaracetam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 9 sitesJapan
- Study dates
- 4 Jan 2019to 27 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has, in the opinion of the Investigator, adequate seizure control for participation in the study, and is willing and able to comply with all study requirements including hospitalization, multiple blood draws, and intravenous (iv) injection
- Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- Japanese subject is currently enrolled in EP0085 [NCT03250377] receiving oral brivaracetam (BRV) for the treatment of partial seizures and has been enrolled for at least 8 weeks prior to entry into EP0118
- Subject has been on a stable twice daily dosage regimen of BRV 50 mg/day to 200 mg/day for the 4 weeks prior to entry into EP0118
- Subject has been receiving concomitant antiepileptic drug (AED(s)) at doses that have remained stable for the 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) prior to entry into EP0118
- Subject has been receiving drugs with possible central nervous system (CNS) effects at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
- Subject has been receiving drugs that significantly influence the metabolism of BRV at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
- Subject has had stable vagal nerve stimulation (VNS) settings for the 4 weeks prior to entry into EP0118, if applicable
Who cannot join
- Subject is receiving an investigational medicinal product (IMP) or unapproved medication other than oral BRV, or using an experimental medical device
- Subject has previously been treated with intravenous (iv) brivaracetam (BRV)
- Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol
- Subject has a confirmed clinically relevant abnormality by electrocardiogram (ECG)
- Subject has a severe medical, neurological, or psychiatric disorder, or abnormal laboratory values which may have an impact on the safety of the subject
- Subject has demonstrated poor compliance with the visit schedule or medication intake in previous BRV studies
Show all 11Show fewer
- Subject has planned participation in any other clinical study of another IMP or device during this study
- Subject is a pregnant or lactating female
- Subject has any medical condition which, in the Investigator's opinion, warrants exclusion
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) "Since Last Visit" at Screening
- Subject has >2x upper limit of normal (ULN) of any of the following prior to Day 1 (from liver function assessment in EP0085): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5x ULN total bilirubin if known Gilbert's syndrome)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Ep0118 116
Asaka
Ep0118 126
Bunkyō City
Ep0118 111
Hamamatsu
Ep0118 121
Itami
Ep0118 142
Kamakura
Ep0118 112
Kōshi
Ep0118 104
Shizuoka
Ep0118 138
Tsukuba
Ep0118 109
Yamagata
About this study
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
The purpose of the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects >=16 years of age with partial seizures with or without secondary generalization and to evaluate the partial seizure frequency after switching from oral administration to iv BRV.
- Being tested
- Brivaracetam
- Keywords
- Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Japanese subjects
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called Briviact
- Pharmaceutical form: Solution for injection
- Concentration: 10 mg/ml
- Route of administration: Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Subjects in this arm will receive open-label Brivaracetam. Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Measured: From study entry until Final Visit (up to 7 days)
Subject withdrawal due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Measured: From study entry until Final Visit (up to 7 days)
Occurrence of Serious Adverse Events (SAEs)
A SAE must meet 1 or more of the following criteria:
- Death
- Life-threatening
- Significant or persistent disability/incapacity
- Congenital anomaly/birth defect
- Initial inpatient hospitalization or prolongation of hospitalization
- Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
Measured: From study entry until Final Visit (up to 7 days)
Secondary outcomes (4)
Partial seizure frequency during the Treatment Period
Partial Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures. The partial seizure frequency will be assessed using the seizure count information recorded on the daily record card (DRC). The written information will be discussed with the subject in order to ensure completeness and accuracy. As a result of the discussion, the Investigator will assess the seizures according to the International League Against Epilepsy (ILAE) codes and record the seizure types and frequency on the DRC.
Measured: During the Treatment Period (from Day 1 to Day 5)
Brivaracetam (BRV) plasma concentration (at Day 1)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 1.
Measured: Day 1
Brivaracetam (BRV) plasma concentration (at Day 2)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 2.
Measured: Day 2
Brivaracetam (BRV) plasma concentration (at Day 5)
The plasma concentration level of brivaracetam 5 minutes postdose on Day 5.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start4 Jan 2019
- Primary completion27 Mar 2021
- Study completion27 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Seizures With or Without Secondary GeneralizationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685630
- Sponsor's protocol ID
- EP0118
- Status last verified
- Apr 2021
- First submitted
- 20 Sep 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT03685630
- Acronym / sponsor ID
- EP0118
- Keywords
- Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Japanese subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 27 Mar 2021 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
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 the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects >=16 years of age with partial seizures with or without secondary generalization and to evaluate the partial seizure frequency after switching from oral administration to iv BRV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam | Experimental | Drug: BrivaracetamSubjects in this arm will receive open-label Brivaracetam. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has, in the opinion of the Investigator, adequate seizure control for participation in the study, and is willing and able to comply with all study requirements including hospitalization, multiple blood draws, and intravenous (iv) injection
- Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- Japanese subject is currently enrolled in EP0085 [NCT03250377] receiving oral brivaracetam (BRV) for the treatment of partial seizures and has been enrolled for at least 8 weeks prior to entry into EP0118
- Subject has been on a stable twice daily dosage regimen of BRV 50 mg/day to 200 mg/day for the 4 weeks prior to entry into EP0118
- Subject has been receiving concomitant antiepileptic drug (AED(s)) at doses that have remained stable for the 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) prior to entry into EP0118
Key exclusion criteria (11 listed)
- Subject is receiving an investigational medicinal product (IMP) or unapproved medication other than oral BRV, or using an experimental medical device
- Subject has previously been treated with intravenous (iv) brivaracetam (BRV)
- Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol
- Subject has a confirmed clinically relevant abnormality by electrocardiogram (ECG)
- Subject has a severe medical, neurological, or psychiatric disorder, or abnormal laboratory values which may have an impact on the safety of the subject
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 |
|---|---|---|
| BrivaracetamAlso: Briviact* Pharmaceutical form: Solution for injection * Concentration: 10 mg/ml * Route of administration: Intravenous injection | Drug | Brivaracetam |
Primary outcome
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
Time frame: From study entry until Final Visit (up to 7 days)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Subject withdrawal due to Adverse Events (AEs)
Time frame: From study entry until Final Visit (up to 7 days)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Occurrence of Serious Adverse Events (SAEs)
Time frame: From study entry until Final Visit (up to 7 days)
A SAE must meet 1 or more of the following criteria: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect * Initial inpatient hospitalization or prolongation of hospitalization * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
4 secondary outcomes
Partial seizure frequency during the Treatment Period
Time frame: During the Treatment Period (from Day 1 to Day 5)
Brivaracetam (BRV) plasma concentration (at Day 1)
Time frame: Day 1
Brivaracetam (BRV) plasma concentration (at Day 2)
Time frame: Day 2
Brivaracetam (BRV) plasma concentration (at Day 5)
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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
001 844 599 2273 (UCB)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivaracetam in people with Partial Seizures With or Without Secondary Generalization and Epilepsy, run by UCB Biopharma S.P.R.L. at 9 sites in Japan.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator (time frame: From study entry until Final Visit (up to 7 days)). The study lists 3 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 13 Apr 2021.