SK Biopharmaceuticals receive drug ministry's approval for clinical phase 3 trial plan for anti--epileptic drug

By Park Sae-jin Posted : March 30, 2023, 15:02 Updated : March 30, 2023, 15:02

[Gettyimages Bank]

SEOUL -- SK Biopharmaceuticals said that the company has received approval from the drug ministry for the clinical phase 3 trial plan for its investigational new drug -- the anti-epileptic drug Cenobamate. The drug is specially designed for primary generalized tonic-clonic seizures in adolescents.
This clinical trial is part of a multinational clinical trial to evaluate the efficacy and safety of Cenobamate in patients with primary generalized tonic-clonic seizures aged between 11 and 18. The trial will be conducted at five institutions in Korea, including Seoul National University Hospital, Boramae Medical Center, Keimyung University Dongsan Medical Center, Chungbuk National University Hospital, and Bundang CHA Medical Center.
About 30 adolescent patients will be randomly assigned to receive either Cenobamate or a placebo drug for about 34 to 37 weeks and can choose to continue treatment with open-label medication for up to one year.
Currently, Cenobamate clinical trials are being conducted in eight countries including South Korea, the United States, Australia, and Germany. The goal of the multinational clinical trial is to widen the age range of patients with the epileptic disease while expanding the types of diseases applicable to Cenobamate. A phase 3 clinical trial for adult patients with partial seizure symptoms is also currently underway in South Korea.
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