Back to resultsStiripentol in Dravet Syndrome
Primary Purpose
Dravet Syndrome
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
stiripentol
Sponsored by
About this trial
This is an expanded access trial for Dravet Syndrome focused on measuring treatment with stiripentol
Eligibility Criteria
Inclusion Criteria:
- Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures
Sites / Locations
- Mayo Clinic in Rochester
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01533506
Brief Title
Stiripentol in Dravet Syndrome
Official Title
Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
No longer available
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome
Keywords
treatment with stiripentol
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
stiripentol
Other Intervention Name(s)
Diacomit
Intervention Description
Stiripentol up to 30 mg/kg/day to control seizures
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Wirrell, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stiripentol in Dravet Syndrome
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