A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Other: Placebo; Drug: Brivaracetam

• Registration Number: NCT00175825
• Lead Sponsor: UCB Pharma

Brief Summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Start: 2005-11-07
• Primary Completion: 2006-06-29
• Study Completion: 2006-06-29
• Results First Submitted: 2017-10-26
• Results First Submitted QC: 2018-08-21
• Results First Posted: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Male/female from 16 to 65 years
• Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
• History of partial onset seizures
• Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
• Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria

• Seizure type IA non-motor as only seizure type
• Seizures occurring only in clusters
• Status epilepticus during the last 2 years before Visit 1
• History of cerebrovascular accident (CVA)
• Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo tablets administered twice a day
Brivaracetam 5 mg/day	Brivaracetam	Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Brivaracetam 20 mg/day	Brivaracetam	Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/day	Brivaracetam	Brivaracetam 50 mg/day, 25 mg administered twice a day

Primary Outcome Measures

Name	Time	Method
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period	During the 7-week Treatment Period	Calculated as 7-day partial onset seizure frequency.

Secondary Outcome Measures

Name	Time	Method
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period	During the 7-week Treatment Period	Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period	During the 7-week Treatment Period	Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period	Baseline, during the 7-week Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period	During the 7-week Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Number of Seizure-free Days Per 4 Weeks	Baseline, during the 7-week Treatment Period	A day was considered seizure-free, if no seizure was reported during 24 hours.
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period	During the 7-week Treatment Period	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period	During the 7-week Treatment Period	A responder was defined as a subject with a \>= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period	During the 7-week Treatment Period	Number of days to first, fifth, and tenth seizure after baseline.
Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period	During the 7-week Treatment Period	Categories of percentage reductions in seizures from baseline were as following: \< -25 %; -25 % to \<25 %; 25 % to \<75 %; 75 % to \<100 %; 100 %.
Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period	During the 7-week Treatment Period	A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.