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| Name | Class |
|---|---|
| The Epilepsy Study Consortium | OTHER |
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The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| YKP3089 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YKP3089 | Drug | Oral dosage form |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo. | At the completion of each cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of serum concentrations of concomitant AEDs during administration of YKP3089 as compared to the placebo day. Assessment of safety/tolerability at multiple dose levels. | At the completion of each cohort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline French, M.D. | NYU MEDICAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | United States | ||
| Cornell Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31292226 | Derived | Kasteleijn-Nolst Trenite DGA, DiVentura BD, Pollard JR, Krauss GL, Mizne S, French JA. Suppression of the photoparoxysmal response in photosensitive epilepsy with cenobamate (YKP3089). Neurology. 2019 Aug 6;93(6):e559-e567. doi: 10.1212/WNL.0000000000007894. Epub 2019 Jul 10. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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| Drug |
|
| New York |
| New York |
| 10021 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of Pennsylvania Epilepsy Center | Philadelphia | Pennsylvania | 19104 | United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |