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# FDA Modifies Partial Hold on Davet Syndrome Drug
- URL: https://www.fdaweb.com/fda-modifies-partial-hold-on-davet-syndrome-drug/
- Published: 2023-03-15T12:00:00.000Z
- Updated: 2026-09-14T18:19:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153981

FDA has modified a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing Phase 1/2a MONARCH study of children and adolescents with Dravet syndrome. “This new 70 mg single dose cohort in MONARCH will complement the ongoing evaluation of multiple doses of 70 mg in the ADMIRAL study,” the company says. STK-001 is a proprietary antisense oligonucleotide, and the first potential new medicine to address the genetic cause of Dravet syndrome, it says.

Dravet syndrome is described as a genetic form of epilepsy characterized by frequent, prolonged and refractory seizures that begin during the first year of life. Current anti-seizure medicines do not adequately control the seizures, the company says.