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Carisbamate for Lennox-Gastaut Syndrome

Phase 3

Recruiting

Research Sponsored by SK Life Science, Inc.

Eligibility Criteria Checklist

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

Must have

Subjects must be age 4-55 years at the time of consent/assent

Must have been <11 years old at the onset of LGS

Must not have

Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study

Benzodiazepine rescue administered on average more than once a week in the month before Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether or not carisbamate can help reduce seizure frequency in people with Lennox-Gastaut Syndrome.

Who is the study for?

This trial is for children and adults aged 4-55 with Lennox Gastaut Syndrome (LGS), experiencing multiple seizure types including drop seizures. Participants must have a history of LGS onset before age 11, be on stable anti-seizure medications, and not have progressive neurological diseases or significant other health issues. Women of childbearing potential must use birth control.

What is being tested?

The study tests the effectiveness of Carisbamate as an additional treatment to reduce drop seizures in those with LGS compared to a placebo. It aims to see if adding Carisbamate helps decrease the frequency of these seizures when taken alongside standard seizure medications.

What are the potential side effects?

While specific side effects for Carisbamate are not listed here, common side effects for seizure medication can include dizziness, fatigue, coordination problems, changes in mood or behavior, skin rashes, and possible interaction with other drugs.

Eligibility Criteria

Inclusion Criteria

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

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I am between 4 and 55 years old.

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My LGS started before I was 11 years old.

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I have Lennox-Gastaut syndrome with more than one type of seizure, including atonic or tonic seizures.

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I have had at least 2 seizures a week that could make me fall in the last month.

Exclusion Criteria

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

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I am scheduled for epilepsy surgery or device insertion during the study.

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I have used benzodiazepines more than once a week in the last month.

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I started a special diet less than 4 weeks ago or often have diarrhea.

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I am allergic to or have had a reaction to carisbamate or its ingredients.

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I am taking Epidiolex and not using any other CBD products.

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I stopped taking vigabatrin 5 months ago and have a normal vision test result.

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I am not taking any strong medication that affects liver enzymes.

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I have not had serious heart problems like a heart attack in the last 2 years.

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I have not had a continuous seizure within the last 12 weeks.

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I have not engaged in any suicidal behavior in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.

Secondary study objectives

Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.

Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.

The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.

Other study objectives

Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.

Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.

Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the double-blind treatment period.

+2 more

Awards & Highlights

Pivotal Trial

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

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Carisbamate 300 mg BID armExperimental Treatment1 Intervention

Age: 4 to \<12y\* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID

Group II: Carisbamate 200 mg BID armExperimental Treatment1 Intervention

Age: 4 to \<12y\* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID

Group III: Placebo matched to 200 mg BID armPlacebo Group1 Intervention

Age: 4 to \<12y\* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID

Group IV: Placebo matched to 300 mg BID armPlacebo Group1 Intervention

Age: 4 to \<12y\* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carisbamate

2013

Completed Phase 3

~690

0 / 14Eligibility criteria met