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NCT Number: NCT04062981

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

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

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carisbamate

Drug

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

Other names: YKP509

Primary outcomes

  1. Concomitant medication

    Time frame: Up to 20 months

    Safety

  2. 12-lead electrocardiograms (ECGs)

    Time frame: Up to 20 months

    Safety

  3. Physical examinations

    Time frame: Up to 20 months

    Safety

  4. Seizure Frequency

    Time frame: Up to 20 months

    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.

Secondary outcomes

  1. Safety- adverse events

    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.

    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

Sponsors and collaborators

Lead sponsor

SK Life Science, Inc.

Industry

Registry information

Official study title

Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2019
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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