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

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01728077

Run by

UCB Pharma SA

People needed

26

Starts

2012-10-01

Expected to finish

2016-08-01

Last updated by the study team

2018-07-11

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 103 — Little Rock, Arkansas, United States
• 108 — Lexington, Kentucky, United States
• 109 — New York, New York, United States
• 106 — Akron, Ohio, United States
• 110 — Dallas, Texas, United States
• 102 — Salt Lake City, Utah, United States
• 201 — Paris, France
• 303 — Bernau, Germany
• 300 — Kehl-Kork, Germany
• 502 — Seville, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.