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