Brivaracetam for Epilepsy

Recruiting at 30 trial locations

Overseen By UCB Cares

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must be taking: Brivaracetam

Must not be taking: Carbamazepine, Felbamate, Gabapentin, others

Disqualifiers: Paroxysmal nonepileptic seizures, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

84 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

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.

Inclusion Criteria

I agree to use birth control and not donate sperm during and for 2 days after treatment.

I was in the N01269 study, have CAE or JAE, and could benefit from long-term BRV.

Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator

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

I have had seizures that are not caused by epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brivaracetam doses as oral solution or film-coated tablet twice per day

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Open-label extension

Participants continue to receive brivaracetam to evaluate long-term safety, tolerability, and efficacy

26 months

Treatment Details

Interventions

• Brivaracetam

Trial Overview 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.

Participant Groups

Group I: Brivaracetam arm Experimental Treatment 2 Interventions

Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.

Brivaracetam is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Briviact for:

• Partial-onset seizures with or without secondary generalisation

Approved in United States as Briviact for:

• Focal (partial) onset seizures in epilepsy patients 1 month of age and older

Approved in Canada as Brivlera for:

• Partial-onset seizures with or without secondary generalisation

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven