Overview
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Status:
Approved for marketing
Approved for marketing
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
Expanded access to Stiripentol for patients with Dravet Syndrome.Details
Lead Sponsor:
Children's Hospital Medical Center, CincinnatiTreatments:
Stiripentol
Criteria
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