A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3
- Conditions
- Partial Onset SeizuresMedDRA version: 9.1 Level: LLT Classification code 10015037 Term: Epilepsy
- Registration Number
- EUCTR2006-006344-59-GB
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 399
• Subjects from 16 to 70 years, both inclusive. Subjects under 18 years may only be
included where legally permitted and ethically accepted.
• Well-characterized focal epilepsy or epileptic syndrome according to the ILAE
classification (1).
• Subjects with a history of partial onset seizures whether or not secondarily generalizedn(Type I seizures according to the ILAE classification).
• Subjects having at least two partial onset seizures whether or not secondarily
generalized per month during the three months preceding Visit 1 (V1).
• Subjects having at least eight partial onset seizures whether or not secondarily
generalized during the 8-week Baseline Period.
• Subjects being uncontrolled while treated by one to two permitted concomitant AED(s).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V3.
• History or presence of status epilepticus during the year preceding V1 or during
Baseline.
• Subject taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the Treatment Period.
• Subjects taking any drug that may significantly influence the metabolism of BRV
(CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable
at least one month before V1, and is expected to be kept stable during the Treatment Period.
• History of cerebrovascular accident (CVA), including transient ischemic attack (TIA),
in the last six months.
• Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing
(i.e. not expected to stay stable during trial participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method