Back to resultsA Study of Brivaracetam in Subjects With Partial Onset Seizures
Primary Purpose
Epilepsy, Focal
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Brivaracetam
Brivaracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Focal focused on measuring Epilepsy, Focal Epilepsy, Partial Onset Seizures, Brivaracetam
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Brivaracetam 50 mg/day
Brivaracetam 150 mg/day
Arm Description
Matching placebo tablets administered twice a day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam 150 mg/day, 75 mg administered twice a day
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period
Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
Responder rate in partial onset seizures (type I) over the 7-week Maintenance period
A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.
Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period
The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to ≤ 100%, and 100%.
Percentage of seizure-free subjects over the 7-week Maintenance period
Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods
Time to N-th seizure in the Maintenance period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00175929
Brief Title
A Study of Brivaracetam in Subjects With Partial Onset Seizures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Focal
Keywords
Epilepsy, Focal Epilepsy, Partial Onset Seizures, Brivaracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets administered twice a day
Arm Title
Brivaracetam 50 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 50 mg/day, 25 mg administered twice a day
Arm Title
Brivaracetam 150 mg/day
Arm Type
Experimental
Arm Description
Brivaracetam 150 mg/day, 75 mg administered twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
Primary Outcome Measure Information:
Title
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
Description
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
Time Frame
7-week maintenance period
Secondary Outcome Measure Information:
Title
Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Responder rate in partial onset seizures (type I) over the 7-week Maintenance period
Description
A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period
Description
The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to ≤ 100%, and 100%.
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Percentage of seizure-free subjects over the 7-week Maintenance period
Time Frame
During the Maintenance period (approximately 7 weeks)
Title
Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods
Time Frame
Baseline through Maintenance period (approximately 11 weeks)
Title
Time to N-th seizure in the Maintenance period
Time Frame
During the Maintenance period (approximately 7 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Brugge
Country
Belgium
City
Brussels
Country
Belgium
City
Duffel
Country
Belgium
City
Edegem
Country
Belgium
City
Leuven
Country
Belgium
City
Liege
Country
Belgium
City
Beroun
Country
Czech Republic
City
Brno
Country
Czech Republic
City
Ceske Budejovice
Country
Czech Republic
City
Praha 1
Country
Czech Republic
City
Praha 5
Country
Czech Republic
City
Kuopio
Country
Finland
City
Oys (Oulu)
Country
Finland
City
Tampere
Country
Finland
City
Angers Cedex 1
Country
France
City
Bethune
Country
France
City
Dijon
Country
France
City
Grenoble Cedex 9
Country
France
City
Lille
Country
France
City
Lyon
Country
France
City
Marseille
Country
France
City
Montpellier Cedex 5
Country
France
City
Nancy
Country
France
City
Paris
Country
France
City
Rennes
Country
France
City
Strasbourg
Country
France
City
Tain L'Hermitage
Country
France
City
Toulouse Cedex 04
Country
France
City
Berlin
Country
Germany
City
Bielefeld
Country
Germany
City
Bonn
Country
Germany
City
Chemnitz
Country
Germany
City
Erlangen
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Freiburg
Country
Germany
City
Kehl
Country
Germany
City
Munchen
Country
Germany
City
Ulm
Country
Germany
City
Heemstede
Country
Netherlands
City
Heeze
Country
Netherlands
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Madrid
Country
Spain
City
Valencia
Country
Spain
City
Vigo
Country
Spain
City
Bucks
Country
United Kingdom
City
Cambridge
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Hartshill
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Newcastle
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35285519
Citation
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.
Results Reference
derived
PubMed Identifier
33461041
Citation
Ben-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.
Results Reference
derived
PubMed Identifier
31937513
Citation
Brandt 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.
Results Reference
derived
PubMed Identifier
22813235
Citation
Van 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.
Results Reference
derived
Learn more about this trial
A Study of Brivaracetam in Subjects With Partial Onset Seizures
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