New epilepsy drug tested for Long-Term safety in kids
NCT ID NCT06315322
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 6 times
Summary
This study looks at the long-term safety of the drug brivaracetam in children and teenagers with childhood absence epilepsy or juvenile absence epilepsy. About 120 participants who have already taken the drug in earlier studies will continue treatment and be monitored for side effects. The goal is to see if the drug is safe to use over a long period to control seizures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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70 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ep0224 20321
Tbilisi, Georgia
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Ep0224 20322
Tbilisi, Georgia
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Ep0224 20323
Tbilisi, Georgia
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Ep0224 20324
Tbilisi, Georgia
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Ep0224 40629
Roma, Italy
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Ep0224 40769
Bucharest, Romania
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Ep0224 40770
Timișoara, Romania
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Ep0224 40772
Dubnica nad Váhom, Slovakia
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Ep0224 50140
Birmingham, Alabama, 35233-2110, United States
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Ep0224 50638
New Brunswick, New Jersey, 08901, United States
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Ep0224 50640
Winston-Salem, North Carolina, 27157, United States
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