An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome

NCT04740476 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-04

No results posted yet for this study

Summary

Stoke Therapeutics is evaluating the long-term safety \& tolerability of repeated doses of zorevunersen (STK-001) in patients with Dravet syndrome who previously participated in studies of zorevunersen. Change in seizure frequency and overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.

Conditions

Interventions

DRUG

zorevunersen (STK-001)

zorevunersen drug product is an antisense oligonucleotide administered as an intrathecal injection.

Sponsors & Collaborators

  • Stoke Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Ann Dandurand, MD · Medical Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740476 on ClinicalTrials.gov