An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome
Public ClinicalTrials.gov record NCT04442295. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04442295
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Stoke Therapeutics, Inc
- Industry
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Interventions
- STK-001 - Single Ascending Doses Drug
- STK-001 - Multiple Ascending Doses Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2020
- Primary completion
- Nov 13, 2023
- Completion
- Nov 13, 2023
- Last update posted
- May 17, 2025
2020 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Iowa Hospitals and Clinics; Pediatric Specialty Clinic | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital - Pediatric Epilepsy Program | Boston | Massachusetts | 02114 | — |
| University of Michigan - Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | — |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84108 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Multicare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04442295, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2025 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04442295 live on ClinicalTrials.gov.