Back to resultsTreatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Primary Purpose
Dravet Syndrome
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Stiripentol
Sponsored by
About this trial
This is an expanded access trial for Dravet Syndrome
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01983722
First Posted
November 7, 2013
Last Updated
July 9, 2019
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01983722
Brief Title
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Official Title
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Stiripentol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Eligibility 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
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
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