Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - Any
Updated:7/13/2018
Start Date:October 2012
End Date:August 2016

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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 Phase 3b

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of
Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life
and to explore the direct medical resource use for BRV (for subjects entering N01372 from a
study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of
200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets).
The study will continue until either regulatory approval of BRV has been granted by any
Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor
decides to close the study, or until the BRV development is stopped by the Sponsor.

Inclusion Criteria:

- Subject is male or female and 16 years or older. Subjects under 18 years of age may be
included only where legally permitted and ethically accepted

- Subjects having completed the Treatment Period of an applicable previous BRV study,
and have access to the present study

- Subject for whom the investigator believes a reasonable benefit from the long-term
administration of BRV may be expected

- Female subjects without childbearing potential (postmenopausal for at least 2 years,
bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female
subjects with childbearing potential are eligible if they use a medically accepted
contraceptive method

- Subjects must be able to take the oral film-coated tablets of BRV

Exclusion Criteria:

- Subject has developed hypersensitivity to any components of the Investigational
Medicinal Product (IMP) or comparative drugs as stated in the protocol during the
course of the prior study

- Severe medical, neurological, or psychiatric disorders, or laboratory values that 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 (including an actual attempt,
interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
months as indicated by a positive response ("Yes") to either question 4 or question 5
of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the
previous study or at the Entry Visit of this study if not completed at the last visit
of the previous study
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