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)
