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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Stiripentol's efficacy in Dravet Syndrome patients with SCN1A mutations?
How does Stiripentol compare to other antiepileptic drugs in managing seizures in Dravet Syndrome?
Are there specific biomarkers that predict response to Stiripentol in Dravet Syndrome treatment plans?
What adverse events are associated with long-term Stiripentol use in Dravet Syndrome patients and how are they managed?
What combination therapies involving Stiripentol are being explored for Dravet Syndrome alongside standard-of-care treatments?
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center🇺🇸Cincinnati, Ohio, United States