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Antiepileptic Drug

Brivaracetam for Absence Epilepsy (EXPAND Trial)

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria

Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening period (day -14 to day -2) until end of safety follow-up (up to week 23)

Awards & highlights

EXPAND Trial Summary

This trial is testing a new drug for kids with absence seizures.

Who is the study for?

This trial is for children and young adults aged 2 to 25 with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE). Participants must have frequent seizures, be off psychoactive drugs or on a stable dose, and not have used certain antiepileptic drugs recently. They need normal neurological function and an EEG showing specific seizure patterns. Those under 4 years old require a negative GLUT1DS genetic test.Check my eligibility

What is being tested?

The study tests the effectiveness, safety, and tolerability of brivaracetam as a single treatment compared to placebo in participants with CAE or JAE. It aims to see if brivaracetam can help control seizures without causing significant side effects.See study design

What are the potential side effects?

While the potential side effects of brivaracetam are not listed here, common ones may include drowsiness, dizziness, fatigue, behavioral changes like irritability or aggression, nausea or vomiting. Side effects vary from person to person.

EXPAND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CAE or JAE according to ILAE criteria.

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I have had noticeable absence seizures at least 3 days a week in the last 2 weeks.

Select...

My body weight is at least 9 kg.

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I have not used more than 2 seizure medications and have stopped any seizure medication for enough time before joining this study.

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I am 2-4 years old or had seizures before age 4 and tested negative for GLUT1DS.

EXPAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening period (day -14 to day -2) until end of safety follow-up (up to week 23)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening period (day -14 to day -2) until end of safety follow-up (up to week 23)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening period (day -14 to day -2) until end of safety follow-up (up to week 23) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14

Secondary outcome measures

Electroencephalography

Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14

Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12

+6 more

Side effects data

From 2022 Phase 3 trial • 449 Patients • NCT03083665

19%

Somnolence

14%

Dizziness

Nasopharyngitis

Headache

Upper respiratory tract infection

Large intestine polyp

Calculus ureteric

Pyrexia

Miscarriage of partner

100%

80%

60%

40%

20%

Study treatment Arm

BRV 200 mg/Day

Placebo

BRV 50 mg/Day to OLTP BRV

Placebo to OLTP BRV

BRV 50 mg/Day

BRV 200 mg/Day to OLTP BRV

EXPAND Trial Design

8Treatment groups

Experimental Treatment

Group I: Placebo to BRV optimal dose (defined following Stage 1)Experimental Treatment2 Interventions

Placebo-Controlled (PC) and Active Treatment (AT) Period: Stage 2: Study participants will be randomized in Stage 2 of the study to 'placebo to BRV optimal dose'. Study participants randomized to placebo to brivaracetam (BRV) optimal dose will receive placebo during the PC period followed by BRV optimal dose during the AT period.

Group II: Placebo to 200 mg brivaracetamExperimental Treatment2 Interventions

Placebo-Controlled (PC) and Active Treatment (AT) Period: Stage 1: Study participants randomized to 'placebo to BRV 200mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 200mg/day (or equivalent dose) during the AT period.

Group III: Placebo to 100 mg brivaracetamExperimental Treatment2 Interventions

Placebo-Controlled (PC) and Active Treatment (AT) Period: Stage 1: Study participants randomized to 'placebo to BRV 100mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 100mg/day (or equivalent dose) during the AT period.

Group IV: Placebo received during RDWExperimental Treatment2 Interventions

Randomized Withdrawal (RDW) Period: Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Study participants who are randomized to the placebo arm in the RDW Period will be tapered down to 0 mg and receive 0 mg for 2 weeks.

Group V: Optimal dose of BRV (defined following Stage 1)Experimental Treatment1 Intervention

Placebo-Controlled (PC) and Active Treatment Period (AT): Stage 2: Study participants will be randomized in Stage 2 to receive a fixed dose of the optimal dose of brivaracetam (defined following Stage 1). Study participants randomized to the BRV optimal dose will receive this dose during the 2-week PC period and subsequent 11-week AT period.

Group VI: Brivaracetam received during RDWExperimental Treatment1 Intervention

Randomized Withdrawal (RDW) Period: Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Participants who are randomized to this arm will continue on the Brivaracetam dose they were receiving in the AT period.

Group VII: Brivaracetam 200 mgExperimental Treatment1 Intervention

Placebo-Controlled (PC) and Active Treatment (AT) Period: Stage 1: Study participants randomized to brivaracetam (BRV) 200mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.

Group VIII: Brivaracetam 100 mgExperimental Treatment1 Intervention

Placebo-Controlled (PC) and Active Treatment (AT) Period: Stage 1: Study participants randomized to BRV 100mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brivaracetam

2019

Completed Phase 3

~4510

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,276 Total Patients Enrolled

2 Trials studying Childhood Absence Epilepsy

260 Patients Enrolled for Childhood Absence Epilepsy

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,803 Total Patients Enrolled

1 Trials studying Childhood Absence Epilepsy

140 Patients Enrolled for Childhood Absence Epilepsy

Media Library

Brivaracetam (Antiepileptic Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04666610 — Phase 3

Childhood Absence Epilepsy Research Study Groups: Placebo to 100 mg brivaracetam, Placebo to 200 mg brivaracetam, Placebo to BRV optimal dose (defined following Stage 1), Brivaracetam 100 mg, Optimal dose of BRV (defined following Stage 1), Brivaracetam received during RDW, Placebo received during RDW, Brivaracetam 200 mg

Childhood Absence Epilepsy Clinical Trial 2023: Brivaracetam Highlights & Side Effects. Trial Name: NCT04666610 — Phase 3

Brivaracetam (Antiepileptic Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666610 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please summarize the risks associated with Brivaracetam?

"Brivaracetam has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Will this clinical trial provide new information not yet gathered?

"Brivaracetam was first studied in 2017 by UCB Biopharma S.P.R.L.. The company's initial study involved 227 people and, after Phase 3 approval, 6 more live studies were launched in 16 different countries."

Answered by AI

For which patients is this research project meant?

"This medical trial is looking for 160 participants that suffer from childhood absence epilepsy, are aged 2-25, and meet the following additional requirements: They must be untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt, Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization, Body weight is"

Answered by AI

What do we know about Brivaracetam from other research?

"Brivaracetam is being studied in six clinical trials, four of which are Phase 3. Although the majority of research for Brivaracetam takes place in Poznan and New york, there are a total of 197 locations conducting these medical studies."

Answered by AI

Are there many places in the state where this clinical trial is taking place?

"Right now, there are 17 clinical trial sites looking for patients to enroll. If you choose to participate in this study, it is important to try and pick a location near you so that travelling isn't too much of an inconvenience. The locations recruiting patients right now are Orlando, Wellington, Denver and 14 other places."

Answered by AI

If a patient is under 40, do they still qualify for the research program?

"This trial is only for children aged 2 to 25. Out of the other 270 trials, 111 are for patients under 18 and 159 are for senior citizens over 65 years old."

Answered by AI

How many people are taking part in this research project?

"One hundred and sixty patients who meet the specific inclusion criteria are needed for this clinical trial. The locations of these medical centres include Orlando, Colorado and Wellington, California."

Answered by AI

Are people still being accepted into this trial program?

"That is correct, the clinical trial mentioned is still recruiting patients. Based on the information found on clinicaltrials.gov, the trial was posted on 7/29/2021 and last edited on 11/10/2022. A total of 160 patients are being enrolled at 17 different locations."

Answered by AI

Recent research and studies

Epilepsia OpenJournal

Efficacy and Tolerability of Brivaracetam Monotherapy in Childhood and Juvenile Absence Epilepsy: An Innovative Adaptive Trial Design

Bast, Thomas, Anne‐Liv Schulz, Florin Floricel, Diego Morita, Jody M. Cleveland, and Jan‐Peer Elshoff. 2022. “Efficacy and Tolerability of Brivaracetam Monotherapy in Childhood and Juvenile Absence Epilepsy: An Innovative Adaptive Trial Design”. Epilepsia Open. Wiley. doi:10.1002/epi4.12628.

clinicaltrials.govStudy

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

2021. "A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04666610.

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