Brivaracetam for Epilepsy

Recruiting at 38 trial locations

Overseen By UCB Cares

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Must be taking: Antiepileptic drugs

Disqualifiers: Severe disorders, Generalized epilepsy, 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 5 years

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called brivaracetam (an antiepileptic drug) to determine its safety for long-term use in people with epilepsy. The aim is to assess how well participants tolerate the treatment over time. The trial seeks participants with epilepsy who have not found success with other epilepsy drugs. Eligible participants must have been in a specific previous study or, for those in Japan, have specific types of seizures and EEG results. Those experiencing frequent seizures despite treatment might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be in another study of an investigational medication, which might imply some restrictions.

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

Research has shown that brivaracetam is generally safe for people with epilepsy. One study examined doses of 100 and 200 mg per day and found it effective and safe as an additional treatment for adults with focal (partial) seizures. The FDA has also approved brivaracetam for treating focal seizures, even in children as young as one month old. This approval relies on safety data, indicating it has been tested for safety in humans. While this does not guarantee the absence of side effects, it suggests that most people tolerate brivaracetam well. ^{1 2 3 4 5}

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

Brivaracetam is unique because it offers a refined approach to treating epilepsy by specifically targeting synaptic vesicle protein 2A (SV2A), which plays a crucial role in neurotransmitter release. Unlike many standard treatments that generally focus on sodium channels or GABA receptors, Brivaracetam provides a more targeted mechanism that might reduce seizures with potentially fewer side effects. Researchers are excited about this treatment because it could offer improved efficacy and tolerability, especially for patients who haven't responded well to other medications.

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

Studies have shown that brivaracetam, the treatment being tested in this trial, helps reduce seizures in people with difficult-to-control focal-onset seizures. Many patients experienced at least a 50% reduction in seizures, and some stopped having seizures altogether after starting treatment. Research also shows that brivaracetam is generally well-tolerated, with many patients continuing its use for over a year. This evidence suggests that brivaracetam can be a promising option for effectively managing epilepsy symptoms. ^{2 3 6 7 8}

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 adolescents with epilepsy. Eligible participants are those aged ≥4 to <16 years in Japan, or those who have been part of previous studies N01266 or N01349 at any age over 1 month. They must have a diagnosis of focal epilepsy and uncontrolled partial-onset seizures despite treatment with at least one antiepileptic drug.

Inclusion Criteria

I have epilepsy and was part of the N01266 or N01349 study.

You have had an EEG test showing signs of focal epilepsy in the past 10 years (only for people who joined the study directly in Japan).

If you are participating in the study in Japan, you had a positive pregnancy test during the 4-week Screening Period.

Exclusion Criteria

Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results (for directly enrolled (DE) study participants in Japan only)

You have had a severe seizure within the last 30 days before the screening visit.

I had major surgery within the last 6 months (Japan only).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brivaracetam as adjunctive treatment for epilepsy

Up to 5 years

Regular safety visits

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 is testing the long-term safety and tolerability of a medication called Brivaracetam, which is used to treat seizures in individuals diagnosed with epilepsy.

How Is the Trial Designed?

Group I: Brivaracetam Experimental Treatment 1 Intervention

LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/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

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]

In a comprehensive analysis of safety data from 1957 patients, adjunctive brivaracetam (BRV) showed a treatment-emergent adverse event (TEAE) incidence of 66.9%, slightly higher than the 62.8% observed with placebo, indicating a generally acceptable safety profile.

The most common TEAEs with BRV included somnolence, headache, dizziness, and fatigue, with psychiatric-related TEAEs occurring in 11.3% of patients, suggesting that while BRV is effective for focal seizures, monitoring for these side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Brandt, C., Klein, P., Badalamenti, V., et al.[2020]

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]

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/S1525505025003051

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633701/

BRIVA‐ONE study: 12‐month outcomes of brivaracetam ... In our study, monotherapy with BRV reduced seizures in patients who had not received other treatments and in patients who switched from a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02687711

NCT02687711 | Study to Look at How Effective Briviact is ... The primary objective of this study is to determine BRV retention over a 12 month period as a measure of effectiveness in a real world setting. The secondary ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000204898

12-month Effectiveness and Tolerability of Brivaracetam in ... Outcomes: ≥50% seizure reduction from baseline and continuous seizure freedom (CSF; no seizures after baseline) and treatment-emergent adverse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185918/

Brivaracetam: Pharmacology, Clinical Efficacy, and Safety in ... Studies have shown that brivaracetam consistently achieves significant seizure frequency reductions and high responder rates, demonstrating ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01261325

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 ...

8. 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 ...