Status:
NO_LONGER_AVAILABLE
Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies
Lead Sponsor:
Cook Children's Health Care System
Conditions:
Dravet Syndrome
Epileptic Encephalopathies Associated With SCN1A Mutations
Eligibility:
All Genders
6-18 years
Brief Summary
This is an expanded access use of Stiripentol in Dravet Syndrome or epileptic encephalopathies associated with sodium channel mutations who have failed other drugs in an effort to give them the best c...
Detailed Description
The initial dose of Stiripentol will be determined by the prescribing neurologist and titrated up to an initial goal dose of 50 mg/kg/day divided into 2 to 3 doses per day. Further dose increases by 1...
Eligibility Criteria
Inclusion
- 6 months and older
- Diagnosis of Dravet Syndrome or epileptic encephalopathies associated with SCN1A mutations defined as:
- A documented gene mutation reported to result in Dravet syndrome phenotype; OR
- Clinical confirmation of Dravet syndrome by two pediatric neurologists; OR
- Clinical confirmation of other epileptic encephalopathies associated with sodium channel mutations
- Failure of at least 2 therapeutic anticonvulsants (excluding Na Channel blockers) indicative of intractable seizures
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02239276
Last Update
February 5 2020
Active Locations (1)
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1
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104