Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Brivaracetam (ucb 34714)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00175916

N01125

2004-002140-10 (EudraCT Number)

Details and patient eligibility

About

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Enrollment

853 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study
Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected

Exclusion criteria

Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
Poor compliance with visit schedule or medication intake in previous brivaracetam study
Participation in any clinical study of another investigational drug or device during the study
Pregnant or lactating woman