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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: UCB Pharma SA
• Treatments: Brivaracetam

Criteria

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