Brivaracetam for Epilepsy

Recruiting at 48 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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

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.

What data supports the effectiveness of the drug Brivaracetam for epilepsy?

Brivaracetam has been shown to effectively reduce the frequency of partial-onset seizures in adults with epilepsy, with studies indicating it works quickly and is well-tolerated. It binds to a specific protein in the brain with high selectivity, making it more effective than similar drugs like levetiracetam. ^{1 2 3 4 5}

Is Brivaracetam safe for humans?

Brivaracetam has been shown to be generally safe in humans, with studies indicating it is well tolerated across a range of doses. It has a good safety profile, with limited psychiatric side effects and minimal drug interactions, making it easy to use. ^{2 3 4 6 7}

What makes the drug Brivaracetam unique for treating epilepsy?

Brivaracetam is unique because it binds to a specific protein in the brain with much higher selectivity and affinity than similar drugs, which helps reduce seizures more effectively. It is used as an additional treatment for people who still have seizures despite other medications. ^{3 4 6 8 9}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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 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. England pubmed.ncbi.nlm.nih.gov

Brivaracetam add-on treatment in pediatric patients with severe drug-resistant epilepsy: Italian real-world evidence. [2022]

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

A review of the pharmacology and clinical efficacy of brivaracetam. [2020]

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

Brivaracetam: First Global Approval. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Real-life experience with brivaracetam in 101 patients with difficult-to-treat epilepsy-A monocenter survey. [2022]

6. Iran pubmed.ncbi.nlm.nih.gov

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

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

Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. [2020]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Α Multicenter Retrospective Study Evaluating Brivaracetam in the Treatment of Epilepsies in Clinical Practice. [2021]