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

NCT03532516 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-06-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532516 on ClinicalTrials.gov