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Stiripentol in Dravet Syndrome

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ClinicalTrials.gov Identifier: NCT01533506
Recruitment Status : No longer available
First Posted : February 15, 2012
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
Elaine C. Wirrell, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Dravet Syndrome Drug: stiripentol

Study Design
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Study Type : Expanded Access
Official Title: Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome
Study Start Date : February 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Interventions
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Intervention Details:
    Drug: stiripentol
    Stiripentol up to 30 mg/kg/day to control seizures
    Other Name: Diacomit
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures
Contacts and Locations
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Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533506


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elaine Wirrell, MD Mayo Clinic
More Information
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Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Responsible Party: Elaine C. Wirrell, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01533506     History of Changes
Other Study ID Numbers: 12-000690
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by Elaine C. Wirrell, Mayo Clinic:
treatment with stiripentol

Additional relevant MeSH terms:
Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Epilepsy
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stiripentol
Anticonvulsants