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NCT04442295 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome
A Phase 1 study, sponsored by Stoke Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT04442295 is a Phase 1 study that has completed, run by Stoke Therapeutics. The registered enrollment target is 62 participants.
The verdict
NCT04442295, a Phase 1 study, has completed, sponsored by Stoke Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Stoke Therapeutics is evaluating the safety and tolerability of single and multiple ascending doses of STK-001 in patients with Dravet syndrome. Change in seizure frequency, overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.
Interventions
- DRUG STK-001 - Single Ascending Doses
- DRUG STK-001 - Multiple Ascending Doses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04442295
The ClinicalTrials.gov registry entry for NCT04442295 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stoke Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which STK-001 - Single Ascending Doses is the first listed.
NCT04442295 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04442295 about?
NCT04442295 is a clinical study titled "An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome". Stoke Therapeutics is evaluating the safety and tolerability of single and multiple ascending doses of STK-001 in patients with Dravet syndrome. Change in seizure frequency, overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.
What is the current status of trial NCT04442295?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2020-06-29. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT04442295?
The interventions under investigation include: STK-001 - Single Ascending Doses (DRUG), STK-001 - Multiple Ascending Doses (DRUG).
Who is sponsoring clinical trial NCT04442295?
This trial is sponsored by Stoke Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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