Clinical trial

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

Name

YKP509C002

Description

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

Trial arms

Trial start

2019-05-03

Estimated PCD

2022-12-14

Trial end

2022-12-14

Status

Completed

Phase

Early phase I

Treatment

Carisbamate

An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)

Arms:

Cohort I, Cohort II, Cohort III, Cohort IV

Other names:

YKP509

Size

Primary endpoint

Concomitant medication

Up to 20 months

12-lead electrocardiograms (ECGs)

Up to 20 months

Physical examinations

Up to 20 months

Seizure Frequency

Up to 20 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-Label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through early termination (ET)/end of study (EOS) visit', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

Updated at

2024-04-04

1 organization

1 product

1 indication

Organization

SK Life Science

Product

Carisbamate

Indication

Lennox-Gastaut syndrome