ongwing: An extension study for patients with Dravet syndrome, a severe form of epilepsy, who previously participated in studies of STK-001 in the United Kingdom
- Conditions
- Dravet syndrome (participants =2.5 years of age)Nervous System Diseases
- Registration Number
- ISRCTN12811235
- Lead Sponsor
- Stoke Therapeutics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
1. Completed dosing with STK-001 and the End of Study Visit in Study STK 001-DS-102, with an acceptable safety profile per the Investigator's judgment
2. Satisfactory compliance with study visits and procedures in Study STK 001-DS-102 per Investigator and Sponsor judgment
3. Completed Study STK-001-DS-102 within 4 weeks of the start of their participation in Study STK-001-DS-502, unless approved by the Sponsor
1. Met any withdrawal criteria from Study STK-001-DS-102
2. Current treatment as maintenance therapy with an antiepileptic drug acting primarily as a sodium channel blocker including phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide
3. Clinically significant unstable medical conditions other than epilepsy
4. Clinically relevant symptoms or a clinically significant illness (in the judgment of the Investigator) in the 4 weeks prior to Screening/Baseline of Study STK-001-DS-502, other than epilepsy
5. Spinal deformity or other condition that may alter the free flow of CSF or has an implanted CSF drainage shunt
6. Prior treatment (or is being treated) with an investigational product (other than STK-001) since participating in Study STK 001 DS-102
7. Participating in an observational study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method