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Anti-epileptic

Brivaracetam for Absence Epilepsy

Phase 3
Recruiting
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants 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
Must not have
Participant has a history or presence of paroxysmal nonepileptic seizures
Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from entry visit up to the safety visit (up to 3 years)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to see how safe and well-tolerated brivaracetam is for individuals with childhood absence epilepsy or juvenile absence epilepsy over a long period of time."

Who is the study for?
This trial is for individuals who have previously participated in specific epilepsy studies (EP0132 or N01269) and have a confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy. They should expect to benefit from long-term Brivaracetam use, agree to contraception guidelines, and provide informed consent.
What is being tested?
The study tests the long-term safety and tolerability of Brivaracetam, an anti-epileptic drug, given as either a film-coated tablet or oral solution to those with certain types of epilepsy.
What are the potential side effects?
While not explicitly listed here, common side effects of Brivaracetam may include drowsiness, dizziness, fatigue, nausea and behavioral changes. Each person's experience with side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male and agree to use birth control and not donate sperm during and for 2 days after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures that are not caused by epilepsy.
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My liver is not working properly.
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I am not using any experimental drugs or devices besides BRV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from entry visit up to the safety visit (up to 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from entry visit up to the safety visit (up to 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs) during the study
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
Secondary study objectives
Incidence of IMP related TEAEs during the study
Incidence of serious adverse events (SAEs) during the study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brivaracetam armExperimental Treatment2 Interventions
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
113 Previous Clinical Trials
23,029 Total Patients Enrolled
~80 spots leftby Mar 2030
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