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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062981
Other study ID # YKP509C002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 3, 2019
Est. completion date December 14, 2022

Study information

Verified date April 2024
Source SK Life Science, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 14, 2022
Est. primary completion date December 14, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States 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 UW Valley Medical Center Renton Washington
United States The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center) Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
SK Life Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concomitant medication Safety Up to 20 months
Primary 12-lead electrocardiograms (ECGs) Safety Up to 20 months
Primary Physical examinations Safety Up to 20 months
Primary 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 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 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.
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