An international, randomized, double-blind, parallel-group, placebo-controlled, flexible dose study: evaluation of the safety and efficacy of brivaracetam in subjects (>=16 to 70 years old) suffering from localization-related or generalized epilepsy.

• Conditions: ocalization-related or generalized epilepsy; MedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy

• Registration Number: EUCTR2006-006346-34-DE
• Lead Sponsor: CB Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

• Subjects from 18 to 70 years, both inclusive.
• Subjects with well-characterized localization-related epilepsy or generalized epilepsy according to the ILAE classification (1).
• For subjects suffering from:
• localization-related epilepsy (1): subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1 according to ILAE classification (2).
• generalized epilepsy (1): subjects having at least 2 Type II seizure days per month during the 3 months preceding V1 according to the ILAE classification (2).
• For subjects suffering from:
• localization-related epilepsy (1): subjects having at least 4 partial onset seizures whether or not secondarily generalized during the 4-week Baseline Period
according to the ILAE classification (2).
• generalized epilepsy (1): subjects having at least 4 Type II seizure days during the 4-week Baseline Period according to the ILAE classification (2).
• Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AED(s).
Vagal Nerve Stimulation (VNS) is allowed and will not be counted as a concomitant
AED.
• Permitted concomitant AED(s) and VNS (implanted for at least 9 months) being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital and primidone) before V1 and expected to be kept stable during the Treatment Period. Benzodiazepine (BZD) taken more than once a week (for any indication) will be considered as a concomitant AED.
• Presence of a brain MRI/CT scan performed within the last 2 years. If no previous brain MRI/CT scan is available, a brain MRI has to be scheduled during the baseline period.
Are the trial subjects under 18? no
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

Exclusion Criteria

• Subjects suffering from epilepsies and syndromes undetermined whether focal or
generalized (classification 3 according to the ILAE classification (1)).
• Subjects suffering from special syndromes (classification 4 according to the ILAE
classification (1)).
• For subjects suffering from localization-related epilepsy (1): history or presence of
seizures occurring only in clusters (too frequently or indistinctly separated to be
reliably counted) before V2 or occurring only as type 1A non-motor.
• History or presence of status epilepticus during the year preceding V1 or during
Baseline.
• History or presence of known pseudo-seizures.
• Subjects taking any drug with possible CNS effects except if stable from at least 1
month before V1 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 1 month before V1, and is expected to be kept stable during the Treatment
Period.
• History of cerebrovascular accident (CVA), including transient ischemic attack (TIA),
within the last 6 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.
• Subjects institutionalized by order of judicial or administrative authorities.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified