MedTrace Logo

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

NCT04062981 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-04-04

No results posted yet for this study

Summary

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

Conditions

  • Lennox Gastaut Syndrome

Interventions

DRUG

Carisbamate

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

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Kamin, MD · SK Life Science, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2022-12-14
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062981 on ClinicalTrials.gov