A Study of Brivaracetam in Subjects With Partial Onset Seizures
NCT ID: NCT00175929
Last Updated: 2015-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2005-05-31
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo tablets administered twice a day
Placebo
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)
Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam
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)
Brivaracetam 150 mg/day
Brivaracetam 150 mg/day, 75 mg administered twice a day
Brivaracetam
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)
Interventions
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Placebo
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)
Brivaracetam
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)
Brivaracetam
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Bruges, , Belgium
Brussels, , Belgium
Duffel, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Liège, , Belgium
Beroun, , Czechia
Brno, , Czechia
České Budějovice, , Czechia
Prague, , Czechia
Kuopio, , Finland
Oys (Oulu), , Finland
Tampere, , Finland
Angers, , France
Béthune, , France
Dijon, , France
Grenoble, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nancy, , France
Paris, , France
Rennes, , France
Strasbourg, , France
Tain-l'Hermitage, , France
Toulouse, , France
Berlin, , Germany
Bielefeld, , Germany
Bonn, , Germany
Chemnitz, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Kehl, , Germany
München, , Germany
Ulm, , Germany
Heemstede, , Netherlands
Heeze, , Netherlands
Gdansk, , Poland
Katowice, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Warsaw, , Poland
Madrid, , Spain
Valencia, , Spain
Vigo, , Spain
Bucks, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Hartshill, , United Kingdom
Liverpool, , United Kingdom
Newcastle, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2004-001856-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01114
Identifier Type: -
Identifier Source: org_study_id
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