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 |
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).
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.
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
We found this trial at
44
sites
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