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.
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.
Other Name: Briviact
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
UCB Cares
+1 844 599 - 2273
UCBCares@ucb.com
UCB Cares, Study Director
001 844 599 2273 (UCB)