A Study of Brivaracetam in Subjects With Partial Onset Seizures

Conditions

Epilepsy, Focal

Keywords

Epilepsy, Focal Epilepsy, Partial Onset Seizures, Brivaracetam

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

Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C.

2020-12-0412 citations

10.1016/j.eplepsyres.2020.106526

Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis.

Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J.

2020-01-1230 citations

10.1016/j.yebeh.2019.106864

Pharmacokinetic interaction of brivaracetam on other antiepileptic drugs in adults with focal seizures: Pooled analysis of data from randomized clinical trials.

Moseley BD, Otoul C, Staelens L, Stockis A.

2019-10-1410 citations

10.1016/j.eplepsyres.2019.106218

Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies.

Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K.

2016-06-2291 citations

10.1212/wnl.0000000000002864

Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures.

Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P.

2016-06-0655 citations

10.1111/epi.13416

Seizure and Quality of Life Outcomes in Patients with Long-Term Adjunctive Brivaracetam Treatment for Partial-Onset Seizures (P2.032)

Manuel Toledo, Patrick Kwan, Martin Johnson, Simon Borghs, Klaus Eckhardt et al. (7 authors)

Neurology2016-04-05

10.1212/wnl.86.16_supplement.p2.032

Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial.

Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P.

2012-07-19110 citations

10.1111/j.1528-1167.2012.03598.x

Interventions

OTHERPlacebo

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)

DRUGBrivaracetam

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Partial onset seizure frequency (Type I) per week over the 7-week maintenance period	7-week maintenance period	Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

Secondary

Measure	Time frame	Description
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)	A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.
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 seizure-free subjects over the 7-week Maintenance period	During the Maintenance period (approximately 7 weeks)	—
Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods	Baseline through Maintenance period (approximately 11 weeks)	—
Time to N-th seizure in the 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)	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%.

Countries

Belgium, Czechia, Finland, France, Germany, Netherlands, Poland, Spain, United Kingdom

Outcome results

None listed