Brivaracetam for Absence Epilepsy

Recruiting at 26 trial locations

Overseen By UCB Cares

Age: Any Age

Sex: Any

Trial Phase: Phase 3

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 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: Up to 3 years

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the long-term safety and tolerability of brivaracetam for individuals with childhood or juvenile absence epilepsy. Absence epilepsy causes brief periods of staring or zoning out, impacting daily life. Participants will receive varying doses of brivaracetam to assess its effectiveness over time. Ideal candidates have already participated in a specific previous study and have a confirmed diagnosis of childhood or juvenile absence epilepsy. As a Phase 3 trial, this study is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that brivaracetam is likely to be safe for humans?

Research has shown that brivaracetam is generally safe for people. The FDA has approved it to treat focal seizures (a type of epilepsy) in children as young as one month old, based on strong safety evidence.

In studies with adults and children who have different types of seizures, participants tolerated brivaracetam well. The most common side effects included fatigue, headaches, and dizziness, which were usually mild.

For absence epilepsy, specific safety information is still being gathered. However, early results suggest it should also be safe for this condition, similar to others. This ongoing research aims to confirm its long-term safety and effectiveness for absence epilepsy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for epilepsy?

Brivaracetam is unique because it offers a fresh approach to treating absence epilepsy, which is typically managed with medications like ethosuximide, valproic acid, or lamotrigine. This treatment stands out due to its mechanism of action; it targets synaptic vesicle protein 2A (SV2A), which may lead to better control of seizures. Researchers are excited about brivaracetam because it might provide improved efficacy and fewer side effects compared to existing therapies, potentially offering a new lifeline for those who don't respond well to current treatments.

What evidence suggests that brivaracetam might be an effective treatment for absence epilepsy?

Research has shown that brivaracetam helps manage seizures. For individuals with hard-to-control focal seizures, it proved effective over 12 months, benefiting many. In children with generalized seizures, it demonstrated both safety and effectiveness. Promising results appeared with doses between 50 to 200 mg per day, with over half of the patients responding well. Although primarily used for other seizure types, these findings suggest potential benefits for absence epilepsy. In this trial, participants will receive various doses of brivaracetam to evaluate its effectiveness specifically for absence epilepsy. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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

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

Participant has active suicidal ideation prior to study entry

Participant has any medical or psychiatric condition that could jeopardize or compromise participation in the study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brivaracetam

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40614390/

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.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1525505025003099

Long-term tolerability and efficacy of adjunctive ...

In this study, BRV treatment was well tolerated and efficacious in children with generalized-onset seizures. Behavior and emotional functioning scores were ...

3.

withpower.com

withpower.com/trial/phase-3-epilepsy-6-2021-52d6a

Brivaracetam for Absence Epilepsy (EXPAND Trial)

This trial is testing if the drug brivaracetam, used alone, is safe and effective for children and young adults aged 2 to 25 with certain types of epilepsy.

4.

epilepsybehavior.com

epilepsybehavior.com/article/S1525-5050(25)00309-9/pdf

Subgroup a - Epilepsy & Behavior

Conclusions: Long-term adjunctive brivaracetam was well tolerated and efficacious in children with generalized- onset seizures. Behavior/ ...

5.

seizure-journal.com

seizure-journal.com/article/S1059-1311(22)00234-5/pdf

Narrative review of brivaracetam for genetic generalized ...

Results: Promising results were found with doses ranging from 50 to 200 mg/day in terms of efficacy (with > 50% responder rates between 36 and ...

6.

fda.gov

fda.gov/media/114500/download

CLINICAL REVIEW

Brivaracetam oral tablets, oral solution and injection, for intravenous use was approved as adjunctive therapy in the treatment of partial-onset ...

7.

epilepsy.com

epilepsy.com/tools-resources/seizure-medication-list/brivaracetam

Brivaracetam Basic Seizure Medication

Brivaracetam is FDA approved for use for treatment of focal (partial) seizures in children down to 1 month of age. This approval was based on safety data in ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9886169/

Brivaracetam to Treat Partial Onset Seizures in Adults - PMC

The most commonly reported adverse effects that patients who were taking brivaracetam experienced were somnolence, headache, and dizziness.