Status:
ACTIVE_NOT_RECRUITING
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
Lead Sponsor:
Stoke Therapeutics, Inc
Conditions:
Dravet Syndrome
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
Stoke Therapeutics is evaluating the long-term safety \& tolerability of repeated doses of STK-001 in patients with Dravet syndrome who previously participated in studies of STK-001. Change in seizure...
Detailed Description
This study is a multi-center, open-label, multiple-dose, safety extension study for patients who have completed another study of STK-001 and meet study eligibility criteria. STK-001 is an investigatio...
Eligibility Criteria
Inclusion
- Completed dosing with STK-001 and the End of Study Visit in Study STK-001-DS-101 or Study STK-001-DS-102, with an acceptable safety profile per Investigator judgment.
- Had satisfactory compliance with study visits and procedures in Study STK-001-DS-101 or Study STK-001-DS-102 per Investigator and Sponsor judgment.
- Completed Study STK-001-DS-101 or STK-001-DS-102 within 4 weeks of the start of their participation in Study STK-001-DS-501 unless approved by sponsor.
Exclusion
- Met any withdrawal criteria from Study STK-001-DS-101 or STK-001-DS-102.
- Currently treated with an antiepileptic drug (AED) acting primarily as a sodium channel blocker, as maintenance therapy, including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide or cenobamate.
- Clinically significant unstable medical conditions other than epilepsy.
- Clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) at Screening or prior to dosing on Day 1, other than epilepsy.
- Spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt.
- Treated (or is being treated) with an investigational product (other than STK-001) since participating in Study STK-001-DS-101 or STK-001-DS-102.
- Participating in an observational study, they are excluded unless approved by the Sponsor.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04740476
Start Date
January 20 2021
End Date
March 31 2029
Last Update
October 22 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Francisco Medical Center
San Francisco, California, United States, 94158
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Nicklaus Children's Hospital
Miami, Florida, United States, 33155