A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Running, not enrolling · Phase 3

Conditions studied: Childhood Absence Epilepsy, Juvenile Absence Epilepsy

In brief

The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.

Key facts

Study ID

NCT06315322

Run by

UCB Biopharma SRL

People needed

70

Starts

2024-07-10

Expected to finish

2029-11-16

Last updated by the study team

2026-07-17

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
• Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
• Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
• Capable of and provides informed consent/assent, and the participant's parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol

You may not qualify if…

• Participant has a history or presence of paroxysmal nonepileptic seizures
• Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
• Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
• Participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (for participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately to a Mental Healthcare Professional
• Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
• Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure
• Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
• Participant is receiving any investigational drugs or using any experimental devices in addition to BRV
• Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)
• Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator

Where it is running

• Ep0224 50140 — Birmingham, Alabama, United States
• Ep0224 50639 — Orange, California, United States
• Ep0224 50268 — Miami, Florida, United States
• Ep0224 50638 — New Brunswick, New Jersey, United States
• Ep0224 50640 — Winston-Salem, North Carolina, United States
• Ep0224 20321 — Tbilisi, Georgia
• Ep0224 20322 — Tbilisi, Georgia
• Ep0224 20323 — Tbilisi, Georgia
• Ep0224 20324 — Tbilisi, Georgia
• Ep0224 40144 — Abbiategrasso, Italy
• Ep0224 40765 — Messina, Italy
• Ep0224 40764 — Pavia, Italy
• Ep0224 40629 — Roma, Italy
• Ep0224 40766 — Roma, Italy
• Ep0224 40763 — Verona, Italy
• Ep0224 40767 — Bucharest, Romania
• Ep0224 40769 — Bucharest, Romania
• Ep0224 40768 — Iași, Romania
• Ep0224 40770 — Timișoara, Romania
• Ep0224 40771 — Bardejov, Slovakia
• Ep0224 40772 — Dubnica nad Váhom, Slovakia
• Ep0224 20328 — Uzhhorod, Ukraine

Full record on ClinicalTrials.gov

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