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

NCT04062981 | Completed Phase 1 FDA Drug

• 1 other identifier: YKP509C002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (4)

• Concomitant medication

  Safety

  Up to 20 months

• 12-lead electrocardiograms (ECGs)

  Safety

  Up to 20 months

• Physical examinations

  Safety

  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.

  Up to 20 months

Secondary Outcomes (1)

• Safety- adverse events

  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.

Study Arms (4)

Cohort I

EXPERIMENTAL

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

Drug: Carisbamate

Cohort II

EXPERIMENTAL

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

Drug: Carisbamate

Cohort III

EXPERIMENTAL

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

Drug: Carisbamate

Cohort IV

EXPERIMENTAL

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

Drug: Carisbamate

Interventions

Carisbamate DRUG

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

Also known as: YKP509

Cohort I; Cohort II; Cohort III; Cohort IV

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who completed the YKP509C001 study
• Investigator believes subject could benefit from continued exposure to study drug

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Study Sites (5)

Johns Hopkins Hospital

Baltimore, Maryland, 21210, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)

Salt Lake City, Utah, 84113, United States

Location

UW Valley Medical Center

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marc Kamin, MD

  SK Life Science, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: August 20, 2019
• Study Start: May 3, 2019
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (5)