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Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy
Sponsor: UCB Biopharma SRL
Summary
This Compassionate Use Program (CUP) is setup to provide study patients with continuous access to Brivaracetam (BRV) for the time period between closures of the long-term follow up studies N01125, N01199, N01372, N01379, and N01315 and when BRV is commercially available.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-06-01
Healthy Volunteers
Not specified
Conditions
Interventions
Brivaracetam
Patients will start on the individual Brivaracetam (BRV) dose that they had reached at the completion of the previous study. The BRV dose can be adjusted based on the individual patient's seizure control and tolerability; however, the BRV dose may not exceed 200 mg/day in divided (preferably symmetrical) morning and evening doses, taken with or without food. Up- and down-titration steps should be performed in steps of maximum 50 mg/day on a weekly basis. The full down-titration should include a 1-week step at 20 mg/day.