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

SK Life Science, Inc.15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Lennox Gastaut Syndrome

Interventions

CarisbamateDRUG

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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Concomitant medication

Safety

Time frame: Up to 20 months

12-lead electrocardiograms (ECGs)

Safety

Time frame: Up to 20 months

Physical examinations

Safety

Time frame: Up to 20 months

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.

Time frame: Up to 20 months

Secondary Outcomes

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seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.