Trial · NCT04740476
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
NCT04740476, Phase 2, Active not recruiting, Stoke Therapeutics, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome. Trials, record NCT04740476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04740476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
- NCT number
- NCT04740476
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Stoke Therapeutics, Inc
- Conditions
- Dravet Syndrome
- Interventions
- zorevunersen (STK-001)
- First posted
- 2021-02-05
- Last updated
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of multiple doses of zorevunersen | Screening (Day -1) until 6 months after multiple drug dosing | 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. |
| Secondary | Pharmacokinetic (PK) Parameters | Dosing (Day 1) until 6 months after multiple drug dosing | Analysis of plasma concentrations of zorevunersen |
| Secondary | Exposure of zorevunersen in Cerebrospinal Fluid (CSF) | Dosing (Day 1) and every 4 months until last study drug dosing day | Measurement of zorevunersen concentrations |
| Secondary | Measurement of Seizure Frequency | Screening (Day -1) until 6 months after multiple drug dosing | Measurement of Seizure Frequency (by paper diary) |
| Secondary | Change in overall clinical status | Screening (Day -1) until 6 months after multiple drug dosing | Change in overall clinical status as measured by the Clinical Global Impression of Change (CGIC) and the Caregiver Global Impression of Change (CaGIC) |
| Secondary | Change in Quality of Life | Screening (Day -1) until 6 months after multiple drug dosing | Change in quality of life as measured by the EuroQoL-five dimensions, youth version (EQ-5D-Y) instrument |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41780062 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04740476
GET https://conductscience.org/api/trials/v1/NCT04740476/registered