Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Placebo; Drug: Brivaracetam; Drug: Antiepileptic drugs with market authorization available per country

• Registration Number: NCT01261325
• Lead Sponsor: UCB Pharma

Brief Summary

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Disposition First Submitted: 2015-04-27
• Disposition First Submitted QC: 2015-04-27
• Disposition First Posted: 2015-05-15
• Results First Submitted: 2016-03-14
• Results First Submitted QC: 2016-07-04
• Results First Posted: 2016-08-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

• Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
• Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
• Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
• Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
• Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
• Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
• Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED

Exclusion Criteria

• Subject previously randomized within this study or any other prior study with BRV as a dosing arm
• Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
• Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
• Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
• Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
• Subject has history or presence of known psychogenic nonepileptic seizures
• Subject on felbamate with less than 18 months exposure before V1
• Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
• Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
• Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
• Subject is suffering from severe cardiovascular disease or peripheral vascular disease
• Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
• Subject has ongoing psychiatric disease other than mild controlled disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablets administered twice daily
Placebo	Antiepileptic drugs with market authorization available per country	Matching placebo tablets administered twice daily
Brivaracetam 100 mg/ day	Antiepileptic drugs with market authorization available per country	Brivaracetam 50 mg/ day administered twice daily.
Brivaracetam 200 mg/ day	Antiepileptic drugs with market authorization available per country	Brivaracetam 100 mg/ day administered twice daily
Brivaracetam 100 mg/ day	Brivaracetam	Brivaracetam 50 mg/ day administered twice daily.
Brivaracetam 200 mg/ day	Brivaracetam	Brivaracetam 100 mg/ day administered twice daily

Primary Outcome Measures

Name	Time	Method
Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration	12 week Treatment Period	Primary endpoint: United States of America (FDA)
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration	Baseline to 12 week Treatment Period	Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period	Baseline to 12 week Treatment Period
Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period	Baseline to 12 week Treatment Period
Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period	12 week Treatment Period
All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period	12 week Treatment Period
Time to the First Type I Seizure During the Treatment Period	12 week Treatment Period
Time to the Fifth Type I Seizure During the Treatment Period	12 week Treatment Period
Time to the Tenth Type I Seizure During the Treatment Period	12 week Treatment Period

Trial Locations

Locations (207)

001; 🇺🇸 Phoenix, Arizona, United States

013; 🇺🇸 Phoenix, Arizona, United States

006; 🇺🇸 Tucson, Arizona, United States

775; 🇺🇸 Little Rock, Arkansas, United States

045; 🇺🇸 Sacramento, California, United States

025; 🇺🇸 San Francisco, California, United States

060; 🇺🇸 Aurora, Colorado, United States

085; 🇺🇸 Colorado Springs, Colorado, United States

071; 🇺🇸 Miami, Florida, United States

110; 🇺🇸 Miami, Florida, United States

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