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

UCB

Status

Conditions: Epilepsy

Treatments: Drug: Brivaracetam

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03532516

N01317

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

• 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