An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
About the study
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 frequency and overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Dravet Syndrome
Age (in years)
30+
Phase
PHASE2
Participants needed
60
Est. Completion Date
Mar 31, 2029
Treatment type
INTERVENTIONAL
Sponsor
Stoke Therapeutics, Inc
ClinicalTrials.gov identifier
NCT04740476
Study number
STK-001-DS-501
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