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An Open-Label Study to Investigate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Antisense Oligonucleotide STK-001 in Children and Adolescents With Dravet Syndrome

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Trial Profile

An Open-Label Study to Investigate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Antisense Oligonucleotide STK-001 in Children and Adolescents With Dravet Syndrome

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 27 May 2025

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At a glance

  • Drugs Zorevunersen (Primary)
  • Indications Dravet syndrome
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms Monarch
  • Sponsors Stoke Therapeutics

Most Recent Events

  • 02 Dec 2024 According to a Stoke Therapeutics media release, new data from this trial will be presented at the American Epilepsy Society (AES) 2024 Annual Meeting, taking place December 6 - 10, in Los Angeles, California. New data will include 9 patients who received two or three initial doses of 70mg of zorevunersen in a Phase 1/2 study and then continued treatment in an open-label extension (OLE) study, where they received at least two doses of 45mg.
  • 05 Nov 2024 According to a Stoke Therapeutics media release, In August, company announced that the U.S. Food and Drug Administration (FDA) has removed the Partial Clinical Hold on zorevunersen.
  • 05 Nov 2024 According to a Stoke Therapeutics media release, company expects to present data at the American Epilepsy Society (AES) 2024 Annual Meeting, pending acceptance of the abstracts.

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