Brivaracetam for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of brivaracetam, a medication for epilepsy, specifically for children and teens with childhood or juvenile absence epilepsy. Researchers seek to determine if long-term use of brivaracetam is safe and well-tolerated. Participants must have a confirmed diagnosis of childhood or juvenile absence epilepsy and have previously participated in a related study. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for epilepsy.
Do I need to stop taking my current medications to join the trial?
Yes, you will need to stop taking certain medications like carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin to participate in this trial.
Is there any evidence suggesting that brivaracetam is likely to be safe for humans?
Research has shown that brivaracetam is generally safe. In past studies, researchers tested it on both children and adults, including children as young as one month old. This finding suggests the medicine can be safe for young patients with epilepsy.
In one study, many patients were free of seizures just 24 hours after taking brivaracetam, indicating it works quickly without causing serious immediate side effects.
While some people might experience mild side effects, major issues were not commonly reported. This makes brivaracetam a promising option for those considering participation in a trial for epilepsy treatment.12345Why do researchers think this study treatment might be promising for epilepsy?
Brivaracetam is unique because it targets synaptic vesicle protein 2A (SV2A) in the brain, which is different from many traditional epilepsy medications that often target sodium channels or GABA receptors. This distinct mechanism potentially offers a new avenue for controlling seizures in patients who may not respond well to existing treatments like phenytoin, carbamazepine, or valproate. Researchers are particularly excited about brivaracetam because it can be administered as an oral solution or film-coated tablet, providing flexible dosing options that can be tailored to individual patient needs.
What evidence suggests that brivaracetam might be an effective treatment for epilepsy?
Research has shown that brivaracetam helps reduce seizures. Many patients with hard-to-control focal-onset seizures continued using brivaracetam for at least 12 months. Up to 78.4% of patients experienced no seizures when using it as their only medication. Studies also found that it significantly lowered the number of seizures and had a high success rate. This evidence suggests brivaracetam might also help with absence epilepsy, as it has been effective for other seizure types. Participants in this trial will receive various doses of brivaracetam as an oral solution or film-coated tablet twice per day.13678
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 2273 (UCB)
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brivaracetam doses as oral solution or film-coated tablet twice per day
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive brivaracetam to evaluate long-term safety, tolerability, and efficacy
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- Partial-onset seizures with or without secondary generalisation
- Focal (partial) onset seizures in epilepsy patients 1 month of age and older
- Partial-onset seizures with or without secondary generalisation
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
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
Citations
Brivaracetam effectiveness and patient-reported outcomes ...
Brivaracetam was effective in patients with difficult-to-control focal-onset seizures; as shown by brivaracetam retention at 12 months.
Brivaracetam effectiveness and patient-reported outcomes ...
Brivaracetam was effective in patients with difficult-to-control focal-onset seizures; as shown by brivaracetam retention at 12 months.
BRIVA‐ONE study: 12‐month outcomes of brivaracetam ...
Seizure‐freedom rates at 12 months were 75% for first‐line monotherapy and 78.4% after conversion to monotherapy. Brivaracetam monotherapy was ...
:: Journal of Epilepsy Research
Studies have shown that brivaracetam consistently achieves significant seizure frequency reductions and high responder rates, demonstrating ...
Efficacy and safety of brivaracetam for partial-onset ...
This analysis provides Class I evidence that adjunctive BRV is effective in reducing POS frequency in adults with epilepsy and uncontrolled seizures.
Brivaracetam: Pharmacology, Clinical Efficacy, and Safety in ...
71 Results indicated that 58% of patients were seizure-free at 24 hours following BRV administration, with no additional rescue medications ...
Brivaracetam Basic Seizure Medication
This approval was based on safety data in children down to 1 month in age, and seizure outcome data from individuals 16 and above, based on the ...
NCT01261325 | Brivaracetam Efficacy and Safety Study in ...
This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal ...
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