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NCT04740476 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
A Phase 2 study of Dravet Syndrome, sponsored by Stoke Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 17
- Study locations
NCT04740476: Active Phase 2 study of Dravet Syndrome, sponsored by Stoke Therapeutics.
NCT04740476 is a Phase 2 study of Dravet Syndrome that is active but no longer recruiting, run by Stoke Therapeutics. The registered enrollment target is 60 participants, below the 105-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (43% lower). The trial reports 17 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04740476, a Phase 2 study of Dravet Syndrome, is active but no longer recruiting, sponsored by Stoke Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Safety variables for analysis include the incidence, type, severity, and seriousness of AEs, and changes in vital signs, ECG, laboratory, immunogenicity, physical examination, and outcomes on the cerebellar function clinical screening battery.
Conditions Studied
Interventions
- DRUG zorevunersen (STK-001)
Study Locations (17)
Florida
- Nicklaus Children's Hospital - Miami
- Florida Hospital for Children - Orlando
Washington
- Seattle Children's Hospital - Seattle
- MultiCare Health System Institute for Research and Innovation - Tacoma
California
- University of California San Francisco Medical Center - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa Children's Hospital - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What the registry record for NCT04740476 still lists
NCT04740476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 105-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention - of which zorevunersen (STK-001) is the first listed.
NCT04740476 lists 17 locations in 15 states (Florida, Washington, California).
Frequently Asked Questions
What is clinical trial NCT04740476 about?
NCT04740476 is a clinical study titled "An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome". 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 ...
What is the current status of trial NCT04740476?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-01-20. Estimated completion is 2029-03-31.
What conditions does trial NCT04740476 study?
This clinical trial studies the following conditions: Dravet Syndrome.
What interventions are being tested in trial NCT04740476?
The interventions under investigation include: zorevunersen (STK-001) (DRUG).
Who is sponsoring clinical trial NCT04740476?
This trial is sponsored by Stoke Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04740476 being conducted?
This trial has 17 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04740476's enrollment target sits among peer trials
60 6th of 12 higher than 7 of 12 other Dravet Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dravet Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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