Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome (NCT01983722) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
United States
Plain-language summary
Expanded access to Stiripentol for patients with Dravet Syndrome.
Who can participate
Age range6 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Trial details
NCT IDNCT01983722
SponsorChildren's Hospital Medical Center, Cincinnati