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

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01339559

Run by

UCB BIOSCIENCES, Inc.

People needed

767

Starts

2011-05-11

Expected to finish

2019-04-18

Last updated by the study team

2021-08-17

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 013 — Phoenix, Arizona, United States
• 006 — Tucson, Arizona, United States
• 775 — Little Rock, Arkansas, United States
• 025 — San Francisco, California, United States
• 060 — Aurora, Colorado, United States
• 071 — Miami, Florida, United States
• 027 — Orlando, Florida, United States
• 064 — Port Charlotte, Florida, United States
• 023 — Atlanta, Georgia, United States
• 048 — Rome, Georgia, United States
• 039 — Boise, Idaho, United States
• 029 — Chicago, Illinois, United States
• 005 — Peoria, Illinois, United States
• 017 — Winfield, Illinois, United States
• 020 — Ames, Iowa, United States
• 069 — Iowa City, Iowa, United States
• 780 — Lexington, Kentucky, United States
• 008 — Bethesda, Maryland, United States
• 068 — Waldorf, Maryland, United States
• 009 — Golden Valley, Minnesota, United States
• 032 — Lebanon, New Hampshire, United States
• 042 — Hamilton, New Jersey, United States
• 099 — New York, New York, United States
• 022 — New York, New York, United States
• 001 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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