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Antiepileptic

Carisbamate Safety Study in Adult and Pediatric Subjects With 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 the duration of this ol study will be until carisbamate bas been approved for treatment of lgs and is available by prescription, or development of carisbamate for lgs has stopped, whichever is first. this could occur up to 36 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and tolerability of carisbamate, a seizure medication, in patients with Lennox-Gastaut Syndrome. The study focuses on those who have already participated in an earlier study and may benefit from ongoing treatment.

Eligible Conditions
  • Lennox Gastaut Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of this ol study will be until carisbamate bas been approved for treatment of lgs and is available by prescription, or development of carisbamate for lgs has stopped, whichever is first. this could occur up to 36 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of this ol study will be until carisbamate bas been approved for treatment of lgs and is available by prescription, or development of carisbamate for lgs has stopped, whichever is first. this could occur up to 36 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-lead electrocardiograms (ECGs)
Concomitant medication
Physical examinations
+1 more
Secondary study objectives
Safety- adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort IVExperimental Treatment1 Intervention
Subjects 2 to \<6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group II: Cohort IIIExperimental Treatment1 Intervention
Subjects 6 to \<12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group III: Cohort IIExperimental Treatment1 Intervention
Subjects 12 to \<18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Group IV: Cohort IExperimental Treatment1 Intervention
Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
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
41 Previous Clinical Trials
8,922 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
270 Patients Enrolled for Lennox Gastaut Syndrome
Ry R Forseth, Ph.D.Study ChairSK Life Science, Inc.
2 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Lennox Gastaut Syndrome
18 Patients Enrolled for Lennox Gastaut Syndrome
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,316 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
270 Patients Enrolled for Lennox Gastaut Syndrome
Jimmy Schiemann, MDStudy ChairSK Life Science, Inc.
2 Previous Clinical Trials
270 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
270 Patients Enrolled for Lennox Gastaut Syndrome
~2 spots leftby Dec 2025
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