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No longer availableNCT03532516Updated Jun 1, 2026

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

An expanded access record providing Brivaracetam in Epilepsy, sponsored by UCB Biopharma SRL. No longer available. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by UCB Biopharma SRL · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
16 Years and older
Sex
All
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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.

Read the detailed description

The Expanded Access program was not conducted and is not intended to be conducted in the United States.

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Conditions studied

  • Epilepsy

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

Browse Epilepsy studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All

Inclusion criteria

  • Patients with epilepsy who are participating in Brivaracetam (BRV) studies N01125, N01199, N01372, N01379 or N01315
  • Patients for whom the treating physician believes there is a continued benefit from the long-term administration of BRV and other anti-epileptic therapies might not be suitable for the patient
  • Female patients without childbearing potential are eligible
  • Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the Compassionate Use Program (CUP) participation. The patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status
  • Patient is considered reliable and capable of adhering to medication intake.
  • Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician
  • Poor compliance with medication intake in the previous BRV study
  • Participation in any clinical study of another investigation drug or device during the CUP
  • Pregnant or lactating woman
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Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugBrivaracetam

    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.

    Also known as: Briviact

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Where to request access

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03532516
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
May 22, 2018
Last update
Jun 1, 2026

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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