NCT03532516

Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	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.

Timeline

• First posted: 2018-05-22
• Last updated: 2025-06-19