Clinical Trial: YKP3089 (Cenobamate)


An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 (cenobamate) as Adjunctive Therapy in Subjects With Partial Onset Seizures. ClinicalTrials.gov Identifier: NCT NCT02535091

Inclusion Criteria:
•    Ages 18-70 years
•    Partial-onset seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
•    Currently on stable antiepileptic treatment regimen:
•    Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
•    Vagus nerve stimulator (VNS) will not be counted as an AED, but parameters must remain stable for > 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1.

Exclusion Criteria:
•    History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization.
•    History of any drug-induced rash or hypersensitivity reaction.
•    History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
•    Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone

Location:
David Vossler, MD, Krista Kawaguchi, MD & Carole Burton RN, Rainier Clinical Research Center, Inc. Renton, Washington, United States, 98057. Phone 1 425-251-1720
(Posted 10/04/16)

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