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

SK Life Science

Status and phase: Completed; Phase 1

Conditions: Lennox Gastaut Syndrome

Treatments: Drug: Carisbamate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04062981

YKP509C002

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Cohort I

Experimental group

Description:

Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Treatment:

Drug: Carisbamate

Cohort II

Experimental group

Description:

Subjects 12 to \<18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Treatment:

Drug: Carisbamate

Cohort III

Experimental group

Description:

Subjects 6 to \<12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Treatment:

Drug: Carisbamate

Cohort IV

Experimental group

Description:

Subjects 2 to \<6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Treatment:

Drug: Carisbamate