Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Phase 1

Completed

• Conditions: Lennox Gastaut Syndrome
• Interventions: Drug: Carisbamate

• Registration Number: NCT04062981
• Lead Sponsor: SK Life Science, Inc.

Brief Summary

Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).

Detailed Description

Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.

This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.

Study Timeline

• Study Start: 2019-05-03
• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Subjects who completed the YKP509C001 study
• Investigator believes subject could benefit from continued exposure to study drug
• Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study

Exclusion Criteria

• Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
• There are no additional exclusion criteria in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort II	Carisbamate	Subjects 12 to \<18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Cohort III	Carisbamate	Subjects 6 to \<12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Cohort I	Carisbamate	Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Cohort IV	Carisbamate	Subjects 2 to \<6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Primary Outcome Measures

Name	Time	Method
Physical examinations	Up to 20 months	Safety
Concomitant medication	Up to 20 months	Safety
12-lead electrocardiograms (ECGs)	Up to 20 months	Safety
Seizure Frequency	Up to 20 months	An assessment of seizure frequency will be made using a subject/caregiver seizure diary with seizure type and number of daily seizures recorded since the prior visit.

Secondary Outcome Measures

Name	Time	Method
Safety- adverse events	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.	Adverse events assessment for seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown

Trial Locations

Locations (5)

UW Valley Medical Center; 🇺🇸 Renton, Washington, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center); 🇺🇸 Salt Lake City, Utah, United States