Clinical trial NCT00175929: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy, Focal
Keywords: Epilepsy
Focal Epilepsy
Partial Onset Seizures
Brivaracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 157
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period
timeFrame: 7-week maintenance period
Secondary outcomes:
measure: Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Responder rate in partial onset seizures (type I) over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Percentage of seizure-free subjects over the 7-week Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
measure: Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods
timeFrame: Baseline through Maintenance period (approximately 11 weeks)
measure: Time to N-th seizure in the Maintenance period
timeFrame: During the Maintenance period (approximately 7 weeks)
Other outcomes:
Locations:
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
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.