A Phase 2 Multicenter double-blind randomized adjunctive placebo-controlled trial to evaluate the efficacy and safety of YKP3089 in subjects with treatment resistant partial onset seizures
YKP3089 is a novel small molecule that is currently under development as an antiepileptic (and anxiolytic therapeutic) agent in the US and Europe for people with epilepsy; this study specifically investigates partial epilepsy. Epilepsy results from abnormal nerve discharges affecting the nervous system, leading to seizures. Partial epilepsy affects a limited area of the brain; when a seizure spreads throughout the brain it is then called generalized. The purpose of this research study is to compare the efficacy and safety of YKP3089 dosing between 50-400mg, against a placebo to see which is better in lowering the amount of seizures a person with partial epilepsy experiences. YKP3089 must be taken once a day in the morning. The exact mechanism(s) by which YKP3089 exerts its effects remain under active investigation. It is predicted to have a favorable side effect profile when compared to the typical pharmacologic agents currently in use to treat this prevalent condition. The study team will measure this new molecule in the form of the study drug by using seizure diaries, mental health and sleep questionnaires, suicidality assessments, as well as following standard safety procedures such as blood and urine collection. The University of Pennsylvania will only enroll adult subjects aged 18 and 65. A legally authorized representative may sign the Consent and HIPAA Form on behalf of a subject. Subjects who complete the double-blind phase will be given the option to continue treatment as part of an open label extension. All subjects must have a diagnosis of epilepsy and should have a minimum of 3 simple partial with motor component, complex partial, or secondarily generalized seizures per month with no 21 day seizure free period during the 1 month prior to the first screening visit.
- Study Identifier: 814254
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