Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy



Status:Active, not recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - Any
Updated:3/27/2019
Start Date:May 11, 2011
End Date:March 2019

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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

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

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.

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
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