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

Sponsor
SK Life Science, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04062981
Collaborator
(none)
15
Enrollment
5
Locations
4
Arms
44
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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) visitOpen-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
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Actual Study Start Date :
May 3, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort I

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

Drug: Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Other Names:
  • YKP509

    		•
    Experimental: Cohort II

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

    Drug: Carisbamate
    An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
    Other Names:
  • YKP509

    		•
    Experimental: Cohort III

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

    Drug: Carisbamate
    An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
    Other Names:
  • YKP509

    		•
    Experimental: Cohort IV

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

    Drug: Carisbamate
    An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
    Other Names:
  • YKP509

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concomitant medication [Up to 20 months]

      Safety

    2. 12-lead electrocardiograms (ECGs) [Up to 20 months]

      Safety

    3. Physical examinations [Up to 20 months]

      Safety

    4. Seizure Frequency [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 Outcome Measures

    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.]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital Baltimore Maryland United States 21210
    2 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    3 Oregon Health and Science University Portland Oregon United States 97239
    4 The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center) Salt Lake City Utah United States 84113
    5 UW Valley Medical Center Renton Washington United States 98055

    Sponsors and Collaborators

    • SK Life Science, Inc.

    Investigators

    • Study Chair: Jimmy Schiemann, MD, SK Life Science, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SK Life Science, Inc.
    ClinicalTrials.gov Identifier:
    NCT04062981
    Other Study ID Numbers:
    • YKP509C002
    First Posted:
    Aug 20, 2019
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lennox Gastaut Syndrome
    Syndrome

    Study Results

    No Results Posted as of May 16, 2022