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

Primary Purpose

Lennox Gastaut Syndrome

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carisbamate
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lennox Gastaut Syndrome

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital
  • Dartmouth-Hitchcock Medical Center
  • Oregon Health and Science University
  • The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
  • UW Valley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort I

Cohort II

Cohort III

Cohort IV

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Concomitant medication
Safety
12-lead electrocardiograms (ECGs)
Safety
Physical examinations
Safety
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.

Secondary Outcome Measures

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seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown

Full Information

First Posted
May 30, 2019
Last Updated
May 18, 2023
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04062981
Brief Title
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Official Title
Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lennox Gastaut Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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) visit
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort I
Arm Type
Experimental
Arm Description
Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Arm Title
Cohort II
Arm Type
Experimental
Arm Description
Subjects 12 to <18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Arm Title
Cohort III
Arm Type
Experimental
Arm Description
Subjects 6 to <12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Arm Title
Cohort IV
Arm Type
Experimental
Arm Description
Subjects 2 to <6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
Intervention Type
Drug
Intervention Name(s)
Carisbamate
Other Intervention Name(s)
YKP509
Intervention Description
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Primary Outcome Measure Information:
Title
Concomitant medication
Description
Safety
Time Frame
Up to 20 months
Title
12-lead electrocardiograms (ECGs)
Description
Safety
Time Frame
Up to 20 months
Title
Physical examinations
Description
Safety
Time Frame
Up to 20 months
Title
Seizure Frequency
Description
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.
Time Frame
Up to 20 months
Secondary Outcome Measure Information:
Title
Safety- adverse events
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kamin, MD
Organizational Affiliation
SK Life Science, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
UW Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States

12. IPD Sharing Statement

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

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