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Antiepileptic

Carisbamate for Lennox Gastaut Syndrome

Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-3, day 17
Awards & highlights

Study Summary

This study is evaluating whether a drug called carisbamate may help individuals with a certain type of epilepsy.

Eligible Conditions
  • Lennox Gastaut Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-3, day 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-3, day 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The area under the curve (AUC) of carisbamate after a single and multiple doses of carisbamate.
The maximum plasma concentration (Cmax) after a single and multiple doses of carisbamate.
Secondary outcome measures
Safety - adverse events (AEs) reporting after a single and multiple doses of carisbamate.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort IVExperimental Treatment1 Intervention
Subjects 2 to <6 years of age. The starting doses for the single dose and multiple-dose periods will be based on the PK and safety results of the first 3 cohorts.
Group II: Cohort IIIExperimental Treatment1 Intervention
Subjects 6 to <12 years of age. Carisbamate, 60 mg, will be administered on Day 1 and 2 of the single dose period. Carisbamate will be administered at 30 mg twice daily (BID) during the multiple-dose period.
Group III: Cohort IIExperimental Treatment1 Intervention
Subjects 12 to <18 years of age. Carisbamate, 140 mg, will be administered on Day 1 and 2 of the single dose period. Carisbamate will be administered at 70 mg twice daily (BID) during the multiple-dose period.
Group IV: Cohort IExperimental Treatment1 Intervention
Subjects ≥18 years of age. Carisbamate, 200 mg, will be administered on Day 1 and 2 of the single-dose period. Carisbamate will be administered at 100 mg twice daily (BID) during the multiple-dose period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carisbamate
2013
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,829 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
267 Patients Enrolled for Lennox Gastaut Syndrome
Ry R Forseth, Ph.D.Study ChairSK Life Science, Inc.
2 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Lennox Gastaut Syndrome
15 Patients Enrolled for Lennox Gastaut Syndrome
Jimmy Schiemann, MDStudy ChairSK Life Science, Inc.
2 Previous Clinical Trials
267 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
267 Patients Enrolled for Lennox Gastaut Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome
2019. "Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03731715.
~3 spots leftby Apr 2025
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