What side effects are associated with this type of intervention?

Common treatments for Childhood Absence Epilepsy (CAE) that are similar to Brivaracetam include Levetiracetam. The known side effects of Levetiracetam include drowsiness, dizziness, irritability, and behavioral changes such as aggression or mood swings. Other potential side effects are fatigue, headache, and, in some cases, coordination difficulties. It is important to discuss these side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Levetiracetam, an FDA-approved drug that binds to synaptic vesicle protein 2A (SV2A) to modulate neurotransmitter release and reduce seizure activity, is used for treating various types of epilepsy, including Childhood Absence Epilepsy (CAE). Other FDA-approved treatments for CAE include Ethosuximide and Valproic Acid, which have different mechanisms of action but are effective in managing absence seizures.

What other types of research exist?

Promising novel alternatives to Brivaracetam for Childhood Absence Epilepsy patients include Cannabidiol (CBD), which has shown efficacy in reducing seizure frequency in various epilepsy syndromes, and Stiripentol, which has been effective in treating severe myoclonic epilepsy and may offer benefits for CAE. Both alternatives have demonstrated acceptable safety profiles in clinical trials.

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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

Must not have

Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment

Study participant has a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation

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

Pivotal Trial

Summary

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. The drug works by helping to control brain activity to prevent 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.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver is not working properly.

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I do not have any major psychiatric or significant medical conditions that would stop me from participating in the study properly.

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I am on dialysis for end-stage kidney disease.

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My epilepsy is not classified as CAE or JAE.

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I stopped taking rifampicin at least 2 months ago.

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I have had absence status epilepticus.

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I have had seizures that are not caused by epilepsy.

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I have had seizures that are not caused by fever and are not absence seizures.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Upper respiratory tract infection

Headache

Miscarriage of partner

Pyrexia

Calculus ureteric

Large intestine polyp

100%

80%

60%

40%

20%

Study treatment Arm

BRV 200 mg/Day

Placebo

BRV 50 mg/Day

Placebo to OLTP BRV

BRV 50 mg/Day to OLTP BRV

BRV 200 mg/Day to OLTP BRV

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~4500

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Childhood Absence Epilepsy (CAE) include medications like ethosuximide, valproic acid, and lamotrigine, which work by modulating neuronal excitability and neurotransmitter release. Ethosuximide primarily reduces T-type calcium currents in thalamic neurons, which are implicated in the generation of absence seizures. Valproic acid increases gamma-aminobutyric acid (GABA) levels, enhancing inhibitory neurotransmission. Lamotrigine inhibits voltage-gated sodium channels, stabilizing neuronal membranes. Brivaracetam, similar to these treatments, binds to synaptic vesicle protein 2A (SV2A) to modulate neurotransmitter release and reduce seizure activity. This mechanism is particularly relevant for CAE patients as it directly targets the synaptic processes involved in seizure generation, offering a potential for more effective seizure control.

Therapeutic Effects of Time-Limited Treatment with Brivaracetam on Posttraumatic Epilepsy after Fluid Percussion Injury in the Rat.