STK-001-DS-501 - An Open-Label Extension Study for Patients with Dravet Syndrome who Previously Participated in Studies of STK 001

Brief description of study

The purpose of this research study is to look at a possible new therapy for Dravet syndrome, called STK-001. Dravet syndrome is a severe form of epilepsy (a brain disorder that causes seizures). This extension study is open for children and teenagers who completed the treatment and follow-up period of the main study (called the MONARCH Study). The main purpose of the MONARCH Study was to evaluate the safety of different doses of the study drug STK-001. During the MONARCH Study, your child received one of the doses of study drug that was being looked at, varying between 10 mg and 30 mg. In this extension study, your child will receive the same dose of study drug as they received in the main study or a dose that is recommended by the group of medical experts who are overseeing the safety of this study. The main purpose of this extension study is to look at how safe STK-001 (referred to from now on as the “study drug”) is when given every 4 months over a year. The study will also look at how well a person can tolerate receiving multiple doses of the study drug.

Clinical Study Identifier: s21-00437 Identifier: NCT04740476
Principal Investigator: Orrin Devinsky.

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