Stiripentol in Dravet Syndrome

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by (Responsible Party):

Elaine C. Wirrell, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01533506

First received: February 9, 2012

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Purpose

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	Intervention	Phase
Dravet Syndrome	Drug: stiripentol	Phase 4


Study Type:	Expanded Access What is Expanded Access?
Official Title:	Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Genetic and Rare Diseases Information Center resources: Dravet Syndrome

U.S. FDA Resources

Further study details as provided by Mayo Clinic:


Study Start Date:	February 2012
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Stiripentol up to 30 mg/kg/day to control seizures

Other Name: Diacomit

Eligibility


Ages Eligible for Study:	11 Years and older
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Elaine C. Wirrell, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01533506 History of Changes
Other Study ID Numbers:	12-000690
Study First Received:	February 9, 2012
Last Updated:	February 26, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:


treatment with stiripentol

Additional relevant MeSH terms:


Epilepsies, Myoclonic Syndrome Brain Diseases Central Nervous System Diseases Disease Epilepsy Nervous System Diseases	Pathologic Processes Stiripentol Anticonvulsants Central Nervous System Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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