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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I | Experimental | Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
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| Cohort II | Experimental | Subjects 12 to <18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
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| Cohort III | Experimental | Subjects 6 to <12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
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| Cohort IV | Experimental | Subjects 2 to <6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carisbamate | Drug | An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate) |
|
| 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 |
| 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seriousness (yes, no) severity (mild, moderate, severe), affect on carisbamate dosing (increase,reduced, interrupted, withdrawn, no change) and outcome (recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown | The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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Kamin, MD | SK Life Science, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21210 | United States | ||
| Dartmouth-Hitchcock Medical Center |
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| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C518914 | S-2-O-carbamoyl-1-o-chlorophenyl-ethanol |
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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
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|
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center) | Salt Lake City | Utah | 84113 | United States |
| UW Valley Medical Center | Renton | Washington | 98055 | United States |
| D009422 |
| Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |