We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 30 for:    Dravet Syndrome
Previous Study | Return to List | Next Study

Stiripentol in Dravet Syndrome

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533506
First Posted: February 15, 2012
Last Update Posted: February 28, 2013
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.
Information provided by (Responsible Party):
Elaine C. Wirrell, Mayo Clinic
  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
Dravet Syndrome Drug: stiripentol

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:


Further study details as provided by Elaine C. Wirrell, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: Elaine C. Wirrell, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01533506     History of Changes
Other Study ID Numbers: 12-000690
First Submitted: February 9, 2012
First Posted: February 15, 2012
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