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Stiripentol in Dravet Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533506
Expanded Access Status : No longer available
First Posted : February 15, 2012
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Elaine C. Wirrell, Mayo Clinic

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

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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

Intervention Details:
  • Drug: stiripentol
    Stiripentol up to 30 mg/kg/day to control seizures
    Other Name: Diacomit

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures

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 identifier (NCT number): NCT01533506

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Elaine Wirrell, MD Mayo Clinic
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Responsible Party: Elaine C. Wirrell, Consultant, Mayo Clinic Identifier: NCT01533506    
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:
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Epilepsies, Myoclonic
Pathologic Processes
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes