Clinical Trials

Enrolling Now - 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

 

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