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

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

Detailed Description
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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.

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

Conditions
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Lennox Gastaut Syndrome

Intervention / Treatment
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* Drug: Carisbamate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I<br>Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. | Drug: Carisbamate<br>* An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)<br>* Other names: YKP509;|
| Experimental: Cohort II<br>Subjects 12 to <18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. | Drug: Carisbamate<br>* An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)<br>* Other names: YKP509;|
| Experimental: Cohort III<br>Subjects 6 to <12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. | Drug: Carisbamate<br>* An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)<br>* Other names: YKP509;|
| Experimental: Cohort IV<br>Subjects 2 to <6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. | Drug: Carisbamate<br>* An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)<br>* Other names: YKP509;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant medication | Safety | Up to 20 months | 
| 12-lead electrocardiograms (ECGs) | Safety | Up to 20 months | 
| Physical examinations | Safety | Up to 20 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |