Enrollment Closed - 1
“An Open - Label Multicenter safety and pharmacokinetic study of YKP3089 as adjunctive therapy in patients with partial onset seizures.”
PI: Marcelo Lancman, MD
Sponsor: SK Life Science
Mechanism of action: a small molecule, an inhibitor of the slow inactivated sodium channels. May also increase inhibitory transmission by facilitating the release of GABA.
Study Duration: 1 year
Number of visits: 14
First 10 visits are 2 weeks apart. The remaining visits interval > 30 days.
Key Eligibility Criteria:
* Age 18-70 male or female
* Diagnosis of partial epilepsy
* Stable dose of 1-3 AEDs for at least 3 weeks prior to Visit 2
* Ok to have a VNS in addition
* Bezodiazepines taken for sleep, anxiety will be counted as 1 AED out of 3.
* Subject taking phenytoin must not be taking Phenobarbital or primidone
* Subject taking phenobarbital must not be taking phenytoin or primidone
Exclusion Criteria:
* Subjects with evidence of phenytoin or Phenobarbital toxicity
* History of drug-induced rash or hypersensitivity
* PNES
* LGS
* Presence of only non-motor simple partial seizures or generalized epilepsies
* Clinically significant psychiatric illness
* Current use of Felbamate
* History of drug abuse