Brivaracetam for Epilepsy

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment

Study participant has a history or presence of paroxysmal nonepileptic seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from full evaluation visit (month 6) up to the final visit (month 24)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a drug called brivaracetam in children with absence seizures.

Who is the study for?

This trial is for children and young adults aged 2 to 26 with Childhood Absence Epilepsy or Juvenile Absence Epilepsy. Participants must not be pregnant, breastfeeding, and if sexually active, agree to use contraception. They should have no severe medical issues or history of non-epileptic seizures and not be at risk of suicide.

What is being tested?

The study tests the long-term safety and effectiveness of Brivaracetam, either as a tablet or oral solution, in treating absence seizures in pediatric patients with specific types of epilepsy.

What are the potential side effects?

Possible side effects include sleepiness, dizziness, fatigue, behavioral changes like aggression or agitation, gastrointestinal symptoms such as nausea or vomiting, potential allergic reactions to medication components.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver isn't working properly according to my doctor's assessment.

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I have had seizures that are not caused by epilepsy.

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I am on dialysis for end-stage kidney disease.

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I am allergic to brivaracetam or its ingredients, or I have fructose intolerance.

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I am currently taking specific seizure medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from full evaluation visit (month 6) up to the final visit (month 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from full evaluation visit (month 6) up to the final visit (month 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from full evaluation visit (month 6) up to the final visit (month 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with treatment-emergent adverse events (TEAEs)

Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment

Secondary study objectives

Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals

Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit

Percentage of participants with serious adverse events (SAEs) during the study

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