A Study of Brivaracetam in Subjects With Partial Onset Seizures

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy, Focal

Treatments: Other: Placebo; Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00175929

N01114

2004-001856-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 157 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered twice a day

Treatment:

Other: Placebo

Brivaracetam 50 mg/day

Experimental group

Description:

Brivaracetam 50 mg/day, 25 mg administered twice a day

Treatment:

Drug: Brivaracetam

Drug: Brivaracetam

Brivaracetam 150 mg/day

Experimental group

Description:

Brivaracetam 150 mg/day, 75 mg administered twice a day

Treatment:

Drug: Brivaracetam

Drug: Brivaracetam