A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT ID: NCT06315322
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-07-10
2030-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam arm
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
Brivaracetam Film-coated tablet
Drug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
Brivaracetam oral solution
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Interventions
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Brivaracetam Film-coated tablet
Drug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
Brivaracetam oral solution
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Locations
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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 40453
Terrassa, , Spain
Ep0224 20328
Uzhhorod, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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2023-508095-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1303-1174
Identifier Type: OTHER
Identifier Source: secondary_id
EP0224
Identifier Type: -
Identifier Source: org_study_id
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