Stiripentol in Dravet Syndrome

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ClinicalTrials.gov Identifier: NCT01533506

Expanded Access 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

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

Genetics Home Reference related topics: CDKL5 deficiency disorder Genetic epilepsy with febrile seizures plus Pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Genetic and Rare Diseases Information Center resources: Dravet Syndrome Rett Syndrome

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: stiripentol
Stiripentol up to 30 mg/kg/day to control seizures

Other Name: Diacomit

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Contacts and Locations

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

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

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Principal Investigator:	Elaine Wirrell, MD	Mayo Clinic

More Information

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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:

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Syndrome Epilepsies, Myoclonic Spasms, Infantile Rett Syndrome Disease Pathologic Processes Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases	Epileptic Syndromes Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Genetic Diseases, X-Linked Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Stiripentol Anticonvulsants

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