This trial is active, not recruiting.

Condition epilepsy
Treatment brivaracetam
Phase phase 3
Start date April 2011
End date December 2017
Trial size 767 participants
Trial identifier NCT01339559, 2010-020345-27, N01379


This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Brivaracetam with a maximum of 200 mg/day
brivaracetam UCB34714
Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Primary Outcomes

Occurrence of at least one Treatment-emergent Adverse Event
time frame: From entry Visit 1 through End of Treatment (approximately 4 years)
Withdrawal due to Treatment-emergent Adverse Event
time frame: From entry Visit 1 through End of Treatment (approximately 4 years)
Occurrence of a Serious Advere Event
time frame: From entry Visit 1 through End of Treatment (up to approximately 4 years)

Secondary Outcomes

Partial onset seizure (type I) frequency per 28 days during the Evaluation Period
time frame: Evaluation Period (approximately 4 years)
Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period
time frame: Baseline from originating study; Evaluation Period (approximately 4 years)
Responder rate in POS (type I) frequency over the Evaluation Period
time frame: Baseline Period: Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508).

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - Subject completed the Treatment Period of N01358 or the evaluation period of N01258 - Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted - Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected - Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible Exclusion Criteria: - Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies - Severe medical, neurological, or 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 BRV study - Planned participation in any other clinical study of another investigational drug or device during this study - Pregnant or lactating woman - Any medical condition which, in the Investigator's opinion, warrants exclusion - Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

Additional Information

Official title An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
Description The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.