Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
- Conditions
- Dravet Syndrome
- Registration Number
- NCT01983722
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
Expanded access to Stiripentol for patients with Dravet Syndrome.
- Detailed Description
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 6 months and older
- Diagnosis of Dravet Syndrome with intractable seizures
Exclusion Criteria
- Hypersensitivity to the active substance or to any of the excipients
- Past history of psychoses in the form of episodes of delirium
- Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States