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

Lennox Gastaut Syndrome Clinical Trial

Official title:

Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062981
• Other study ID #: YKP509C002
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2019
• Est. completion date: December 14, 2022

Study information

• Verified date: April 2024
• Source: SK Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lennox Gastaut Syndrome
• Syndrome

Intervention

Drug:
• Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)

Locations

Country	Name	City	State
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	UW Valley Medical Center	Renton	Washington
United States	The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concomitant medication	Safety	Up to 20 months
Primary	12-lead electrocardiograms (ECGs)	Safety	Up to 20 months
Primary	Physical examinations	Safety	Up to 20 months
Primary	Seizure Frequency	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.	Up to 20 months
Secondary	Safety- adverse events	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	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.