EpilepsyPhase 3VALORNCT02408523
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
A Phase 3 study testing Lacosamide Tablet and Lasosamide Oral Solution in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 115 sites in 22 countries.
Trial summary
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lacosamide Tablet and Lasosamide Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 115 sitesin 22 countries
- Study dates
- Apr 2015to Jun 2019
- Phase
- Phase 3
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
- Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
- If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
- Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
- Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer
Who cannot join
- Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
- Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
- Subject has an 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 (C-SSRS)
- Subject has >=2x 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). 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 randomized 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, 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.
- Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.
Trial locations and contacts
115 sites in 22 countries.
115 sites in 22 countries
United States27 sites
Sp0982 028
Alabaster, Alabama, 35007
Sp0982 053
Austin, Texas, 78758
Sp0982 007
Bethesda, Maryland, 20817
Sp0982 015
Boise, Idaho, 83702
Sp0982 031
Colorado Springs, Colorado, 80910
Sp0982 036
Danbury, Connecticut, 06810
Sp0982 035
Denver, Colorado, 80202
Sp0982 025
Golden Valley, Minnesota, 55422
Sp0982 050
Greenville, Texas, 75401
Sp0982 034
Houston, Texas, 77025
Sp0982 018
Irvine, California, 92868
Sp0982 011
Jacksonville, Florida, 32224
Sp0982 005
Little Rock, Arkansas, 72205
Sp0982 023
Madison, Wisconsin, 53715
Sp0982 009
New Orleans, Louisiana, 70121
Sp0982 043
New York, New York, 10016
Sp0982 013
Panama City, Florida, 32405
Sp0982 021
Peoria, Illinois, 61637
Sp0982 002
Port Charlotte, Florida, 33952
Sp0982 027
Renton, Washington, 98057
Sp0982 047
San Antonio, Texas, 78207
Sp0982 038
San Antonio, Texas, 78229
Sp0982 008
Santa Monica, California, 90404
Sp0982 045
Springfield, Illinois, 62702
Sp0982 029
St Louis, Missouri, 63131
Sp0982 010
Waldorf, Maryland, 20603
Sp0982 042
Wellington, Florida, 33470
Japan14 sites
Sp0982 907
Asaka
Sp0982 906
Fukuoka
Sp0982 910
Gifu
Sp0982 903
Hamamatsu
Sp0982 902
Hiroshima
Sp0982 913
Itami
Sp0982 912
Kagoshima
Sp0982 914
Kodaira
Sp0982 909
Kokubunji
Sp0982 901
Niigata
Sp0982 911
Ōmura
Sp0982 900
Sapporo
Sp0982 908
Shinjuku-Ku
Sp0982 904
Shizuoka
Poland10 sites
Sp0982 657
Częstochowa
Sp0982 655
Gdansk
Sp0982 658
Gdynia
Sp0982 652
Gliwice
Sp0982 651
Katowice
Sp0982 653
Katowice
Sp0982 654
Katowice
Sp0982 656
Tyniec Mały
Sp0982 650
Warsaw
Sp0982 659
Warsaw
Brazil7 sites
Sp0982 181
Curitiba
Sp0982 180
Florianópolis
Sp0982 186
Passo Fundo
Sp0982 185
Porto Alegre
Sp0982 188
Rio de Janeiro
Sp0982 183
São Paulo
Sp0982 184
São Paulo
Russia7 sites
Sp0982 750
Kazan'
Sp0982 758
Pyatigorsk
Sp0982 755
Saint Petersburg
Sp0982 756
Saint Petersburg
Sp0982 752
Samara
Sp0982 753
Smolensk
Sp0982 757
Yekaterinburg
China6 sites
Sp0982 971
Beijing
Sp0982 976
Changchun
Sp0982 975
Chongqing
Sp0982 097
Fuzhou
Sp0982 973
Hangzhou
Sp0982 972
Shanghai
Germany5 sites
Sp0982 305
Berlin
Sp0982 303
Erlangen
Sp0982 314
Freiburg im Breisgau
Sp0982 311
Marburg
Sp0982 302
München
Spain5 sites
Sp0982 402
Barcelona
Sp0982 406
Córdoba
Sp0982 407
Madrid
Sp0982 404
Málaga
Sp0982 403
Seville
Australia4 sites
Sp0982 980
Chatswood
Sp0982 985
Heidelberg
Sp0982 981
Parkville, Victoria
Sp0982 986
Parkville
Czechia4 sites
Sp0982 550
Ostrava Poruba
Sp0982 553
Prague
Sp0982 556
Prague
Sp0982 552
Zlín
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
- Conditions
- Epilepsy
- Being tested
- Lacosamide Tablet, Lasosamide Oral Solution, Placebo Tablet, Placebo Oral Solution
- Keywords
- Lacosamide, Vimpat, Epilepsy, Children, Primary Generalized Tonic Clonic seizures, Idiopathic Generalized Epilepsy, Adults
- Medical subject headings
- Epilepsy, Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacosamide TabletDrug
Also called Vimpat
- Active Substance: Lacosamide
- Pharmaceutical Form: Film-coated Tablet
- Concentration: 50 mg
- Route of Administration: Oral use
Lasosamide Oral SolutionDrug
Also called Vimpat
- Active Substance: Lacosamide
- Pharmaceutical Form: Oral Solution
- Concentration: 10 mg/ml
- Route of Administration: Oral use
Placebo TabletOther
- Active Substance: Placebo
- Pharmaceutical Form: Film-coated Tablet
- Concentration: 50 mg
- Route of Administration: Oral use
Placebo Oral SolutionOther
- Active Substance: Placebo
- Pharmaceutical Form: Oral Solution
- Concentration: 10 mg/ml
- Route of Administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400 mg/day for adult subjects and pediatric subjects >= 50 kg.
Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30 kg.)
Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30 kg to < 50 kg.) Receives: Drug: Lacosamide Tablet; Drug: Lasosamide Oral Solution |
| Placebo | Placebo comparator | Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400mg/day for adult subjects and pediatric subjects >= 50kg.
Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30kg.)
Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30kg to < 50kg.) Receives: Other: Placebo Tablet; Other: Placebo Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio.
The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis.
The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio.
A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
Measured: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Secondary outcomes (4)
Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.
Measured: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
The secondary efficacy variable was the time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio.
The indicated measured values are the observed number of events of first PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis.
The hazard ratio compares 2 treatment groups for the times to the number of events for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio.
A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
Measured: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator
An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP.
Measured: From Visit 1 (Week -4) to End of Study Period (up to Week 36)
Plasma Concentrations of Lacosamide
Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL).
Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs.
Measured: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionJun 2019
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 EpilepsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408523
- Sponsor's protocol ID
- SP0982
- Other IDs
- 2011-003100-21
- Acronym
- VALOR
- Status last verified
- Nov 2020
- First submitted
- 31 Mar 2015
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT02408523
- Acronym / sponsor ID
- VALOR / SP0982
- Conditions
- Epilepsy
- Keywords
- Lacosamide, Vimpat, Epilepsy, Children, Primary Generalized Tonic Clonic seizures, Idiopathic Generalized Epilepsy, Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Posted 16 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: Lacosamide Tablet, Drug: Lasosamide Oral SolutionLacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400 mg/day for adult subjects and pediatric subjects >= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30 kg.) Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30 kg to < 50 kg.) |
| Placebo | Placebo comparator | Other: Placebo Tablet, Other: Placebo Oral SolutionPlacebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400mg/day for adult subjects and pediatric subjects >= 50kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30kg.) Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30kg to < 50kg.) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
- Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
- If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
- Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
- Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer
Key exclusion criteria (7 listed)
- Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
- Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
- Subject has an 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 (C-SSRS)
- Subject has >=2x 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). 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 randomized 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).
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 |
|---|---|---|
| Lacosamide TabletAlso: Vimpat* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use | Drug | Lacosamide |
| Lasosamide Oral SolutionAlso: Vimpat* Active Substance: Lacosamide * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use | Drug | Lacosamide |
| Placebo Tablet* Active Substance: Placebo * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use | Other | Placebo |
| Placebo Oral Solution* Active Substance: Placebo * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use | Other | Placebo |
Primary outcome
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
4 secondary outcomes
Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator
Time frame: From Visit 1 (Week -4) to End of Study Period (up to Week 36)
Plasma Concentrations of Lacosamide
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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)
115 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide Tablet and Lasosamide Oral Solution in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 115 sites in 22 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 5 inclusion and 7 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, Japan, Poland, Brazil, Russia and 17 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2020). 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?
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24) (time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)). 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 17 Dec 2020.