Epilepsy Juvenile Absence Clinical Trials

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A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

Status: Active_not_recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Ep0224 50140
Birmingham
North Carolina
Ep0224 50640
Winston-salem
New Jersey
Ep0224 50638
New Brunswick
Other Locations
Georgia
Ep0224 20321
Tbilisi
Ep0224 20322
Tbilisi
Ep0224 20323
Tbilisi
Ep0224 20324
Tbilisi
Italy
Ep0224 40629
Roma
Romania
Ep0224 40769
Bucharest
Ep0224 40770
Timișoara
Slovakia
Ep0224 40772
Dubnica Nad Váhom
Time Frame
Start Date: 2024-07-10
Completion Date: 2029-11-16
Participants
Target number of participants: 70
Treatments
Experimental: Brivaracetam arm
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov