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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:

MedlinePlus related topics: Epilepsy Seizures
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:
    Drug: stiripentol
    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
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
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Stiripentol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013