A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Part of paid clinical trials in Hawthorne, New York.

Sponsor
UCB Biopharma SRL
Study ID
NCT04715646
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brivaracetam — DRUG
    Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral

Study Details

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Key Dates

Start date
Mar 11, 2021
Status verified
Jun 2025
Primary completion
Jul 8, 2030
Completion
Jul 8, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brivaracetam
    LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ep0156 259HawthorneNew York10532-
Ep0156 237DurhamNorth Carolina27710-

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