A Study of Brivaracetam in Subjects With Partial Onset Seizures
A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
2 other identifiers
interventional
157
9 countries
56
Brief Summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2005
Shorter than P25 for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedApril 13, 2015
April 1, 2015
10 months
September 9, 2005
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
7-week maintenance period
Secondary Outcomes (8)
Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
During the Maintenance period (approximately 7 weeks)
Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period
During the Maintenance period (approximately 7 weeks)
Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
During the Maintenance period (approximately 7 weeks)
Responder rate in partial onset seizures (type I) over the 7-week Maintenance period
During the Maintenance period (approximately 7 weeks)
Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period
During the Maintenance period (approximately 7 weeks)
- +3 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching placebo tablets administered twice a day
Brivaracetam 50 mg/day
EXPERIMENTALBrivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam 150 mg/day
EXPERIMENTALBrivaracetam 150 mg/day, 75 mg administered twice a day
Interventions
Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
Eligibility Criteria
You may qualify if:
- Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- Subjects with a history of partial onset seizures
- Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
- Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
- Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted
You may not qualify if:
- Seizure type IA non-motor as only seizure type
- History or presence of seizures occurring only in clustered patterns
- History of cerebrovascular accident (CVA)
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (56)
Unknown Facility
Bruges, Belgium
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Brussels, Belgium
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Duffel, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Liège, Belgium
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Beroun, Czechia
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Brno, Czechia
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České Budějovice, Czechia
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Prague, Czechia
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Kuopio, Finland
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Oys (Oulu), Finland
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Tampere, Finland
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Angers, France
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Béthune, France
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Dijon, France
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Grenoble, France
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Lille, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Nancy, France
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Paris, France
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Rennes, France
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Strasbourg, France
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Tain-l'Hermitage, France
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Toulouse, France
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Berlin, Germany
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Bielefeld, Germany
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Bonn, Germany
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Chemnitz, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Kehl, Germany
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München, Germany
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Ulm, Germany
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Heemstede, Netherlands
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Heeze, Netherlands
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Gdansk, Poland
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Katowice, Poland
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Lodz, Poland
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Lublin, Poland
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Szczecin, Poland
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Warsaw, Poland
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Madrid, Spain
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Valencia, Spain
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Vigo, Spain
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Bucks, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Hartshill, United Kingdom
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Liverpool, United Kingdom
Unknown Facility
Newcastle, United Kingdom
Related Publications (4)
Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
PMID: 35285519DERIVEDBen-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
PMID: 33461041DERIVEDBrandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12.
PMID: 31937513DERIVEDVan Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.
PMID: 22813235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
April 13, 2015
Record last verified: 2015-04