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Clinical Trials in the USA / NCT06315322
Active, not recruiting Phase 3

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

NCT06315322 · tracked via the Priya Life Science USA tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2024-07-10
Last updated
2026-08-27

Condition(s) studied

Childhood Absence EpilepsyJuvenile Absence Epilepsy

Investigational drug(s) / intervention(s)

Brivaracetam Film-coated tabletBrivaracetam oral solution

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Ep0224 50140 Birmingham Alabama
Ep0224 50638 New Brunswick New Jersey
Ep0224 50640 Winston-Salem North Carolina
Ep0224 20321 Tbilisi Georgia
Ep0224 20322 Tbilisi Georgia
Ep0224 20323 Tbilisi Georgia
Ep0224 20324 Tbilisi Georgia
Ep0224 40629 Roma Italy
Ep0224 40769 Bucharest Romania
Ep0224 40770 Timișoara Romania
Ep0224 40772 Dubnica nad Váhom Slovakia

More UCB Biopharma SRL trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06315322 on ClinicalTrials.gov ↗ ← All trials in the USA