Brivaracetam for Absence Epilepsy

Recruiting at 21 trial locations

Overseen By UCB Cares

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: UCB Biopharma SRL

Must be taking: Brivaracetam

Must not be taking: Carbamazepine, Felbamate, others

Disqualifiers: Paroxysmal nonepileptic seizures, Hepatic impairment, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin. If you are on any of these, you will need to discontinue them to participate.

Is Brivaracetam safe for humans?

Brivaracetam has been studied for safety in both adults and children with epilepsy, showing it is generally well-tolerated as an add-on therapy for seizures. ^{1 2 3 4 5}

How is the drug brivaracetam different from other treatments for absence epilepsy?

Brivaracetam is unique because it is being studied as a monotherapy (single drug treatment) for absence epilepsy, which is not common for this condition. It binds to a specific protein in the brain with higher selectivity and affinity than similar drugs, potentially offering a more targeted approach. ^{2 3 6 7 8}

Eligibility Criteria

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.

Inclusion Criteria

I am not pregnant or breastfeeding and can follow the birth control requirements.

I was in EP0132 or N01269 trials and have confirmed CAE or JAE.

I (or my guardian) have signed the consent form and agree to follow the study rules.

Exclusion Criteria

I have a history of seizures that are not caused by epilepsy.

Participant has active suicidal ideation prior to study entry

Participant has severe medical, neurological, or psychiatric disorders or laboratory values which could affect safe participation in the study or would preclude appropriate study participation

Trial 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

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brivaracetam (Anti-epileptic)

Trial Overview 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.

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 Canada for the following indications:

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

Findings from Research

Brivaracetam (Briviact) is a new treatment option specifically designed as an adjunctive therapy for patients experiencing partial-onset seizures.

Clinical studies have demonstrated that brivaracetam effectively reduces seizure frequency, making it a valuable addition to existing epilepsy treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam (Briviact): A Novel Adjunctive Therapy for Partial-Onset Seizures. Khaleghi, F., Nemec, EC.[2020]

Brivaracetam, approved in the EU for treating partial-onset seizures, binds more selectively and with 15- to 30-fold higher affinity to the synaptic vesicle glycoprotein 2a (SV2A) compared to levetiracetam, which may enhance its therapeutic effects.

Clinical trials have shown that brivaracetam effectively reduces the frequency of partial-onset seizures, supporting its use as an adjunctive therapy for adults with uncontrolled epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam: First Global Approval. Markham, A.[2018]

The ongoing phase 2/3 trial is evaluating the efficacy, safety, and tolerability of brivaracetam (BRV) as a monotherapy for childhood absence epilepsy (CAE) and juvenile absence epilepsy (JAE) in patients aged 2-25, using a two-stage adaptive design to optimize dosing and reduce trial duration.

This trial includes a robust assessment of seizure activity through 24-hour EEG monitoring and seizure diaries, which will help determine the effectiveness of BRV and may provide a new treatment option for these epilepsy types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. Bast, T., Schulz, AL., Floricel, F., et al.[2022]

In a study of eight pediatric patients with epileptic encephalopathy or unresponsive focal epilepsy, Brivaracetam (BRV) was found to be effective, with all patients experiencing at least a 50% reduction in seizure frequency, and 37.5% becoming seizure-free.

Brivaracetam was particularly effective for patients with epilepsy onset greater than 12 months and a duration of less than 6 years, showing a positive impact on seizures during sleep without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam in treating epileptic encephalopathy and refractory focal epilepsies in patients under 14 years of age. Russo, A., Cuteri, V., Bansal, L., et al.[2022]

In a study of 228 adult patients with epilepsy treated with brivaracetam (BRV) over 12 months, 46.3% experienced a significant reduction in seizure frequency, indicating that BRV can be an effective add-on therapy for managing seizures in a real-world setting.

While BRV showed promising results, particularly in maintaining early responses, the most common side effects included sedation and cognitive slowing, affecting 14.5% of patients, highlighting the need for careful monitoring of tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and tolerability of adjunctive brivaracetam for the treatment of adult epilepsy: An Australian multi-center retrospective real-world observational cohort study. Halliday, AJ., Vogrin, S., Ignatiadis, S., et al.[2023]

Brivaracetam, as an add-on therapy for drug-resistant epilepsy, significantly reduces seizure frequency and increases the likelihood of achieving seizure freedom, based on a review of six trials with 2411 participants.

While brivaracetam is effective, it is associated with a higher rate of treatment withdrawals due to adverse events compared to placebo, indicating that while it can help manage seizures, some patients may experience side effects that lead them to stop treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam add-on therapy for drug-resistant epilepsy. Bresnahan, R., Panebianco, M., Marson, AG.[2022]

In a study of 93 epilepsy patients treated with brivaracetam (BRV), 35.1% of those with more than one seizure per month became responders, with 8.8% achieving complete seizure freedom after an average follow-up of about 4.85 months.

Switching from levetiracetam (LEV) to BRV significantly reduced adverse events, particularly behavioral ones, suggesting that BRV is a safer alternative for patients, especially those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam in the Treatment of Patients with Epilepsy-First Clinical Experiences. Zahnert, F., Krause, K., Immisch, I., et al.[2022]

In a study of 200 adults with focal epilepsy treated with brivaracetam (BRV) over an average follow-up of 707 days, only 6.5% achieved seizure freedom for at least six months, while 23% experienced a significant reduction in seizure frequency.

BRV was generally well-tolerated compared to levetiracetam (LEV), with fewer side effects reported; however, 51% of discontinuations were due to side effects, particularly in patients also taking carbamazepine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of brivaracetam in adults with drug-resistant epilepsy at a single tertiary care center. Green, SF., Hare, N., Kassam, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Brivaracetam (Briviact): A Novel Adjunctive Therapy for Partial-Onset Seizures. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Brivaracetam: First Global Approval. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. [2022]

4. Iran pubmed.ncbi.nlm.nih.gov

Brivaracetam in treating epileptic encephalopathy and refractory focal epilepsies in patients under 14 years of age. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy and tolerability of adjunctive brivaracetam for the treatment of adult epilepsy: An Australian multi-center retrospective real-world observational cohort study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Brivaracetam add-on therapy for drug-resistant epilepsy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Brivaracetam in the Treatment of Patients with Epilepsy-First Clinical Experiences. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Retention of brivaracetam in adults with drug-resistant epilepsy at a single tertiary care center. [2022]