This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatmen

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB PHARMA Inc. (US)
• Treatments: Brivaracetam

Criteria

Inclusion Criteria:

• Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted

• Subjects with epilepsy who have participated in previous brivaracetam trials 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

• Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study

• Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

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 the visit schedule or medication intake in the previous brivaracetam study

• Pregnant or lactating women

• Participation in any clinical study of another investigational drug or device during the study