CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

China, Japan, Malaysia449 participantsStarted 2017-08-22

Plain-language summary

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive * Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method * Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period * Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1 * Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug \[AED\](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED Exclusion Criteria: * Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline * Subject is currently treated with levetiracetam * Subject has taken levetiracetam within 90 days prior to Visit 1

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period

Timeframe: From Baseline to 12-week Treatment Period

Trial details

NCT IDNCT03083665

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2022-12-15

View on ClinicalTrials.gov More Partial Seizures With or Without Secondary Generalization trials

Plain-language summary

Who can participate

Age range

16 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Timeframe: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period

Timeframe: From Baseline to 12-week Treatment Period