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

  • End date
    Dec 31, 2021
  • participants needed
  • sponsor
    SK Life Science, Inc.
Updated on 5 August 2020
Marietta Atienza
Primary Contact
Johns Hopkins Hospital (9.3 mi away) Contact
+11 other location


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.

Treatment Carisbamate
Clinical Study IdentifierNCT04062981
SponsorSK Life Science, Inc.
Last Modified on5 August 2020

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Inclusion Criteria

Is your age greater than or equal to 2 yrs?
Gender: Male or Female
Do you have Lennox Gastaut Syndrome?
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
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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