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Trial record 3 of 30 for:    Dravet Syndrome

Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Expanded access is currently available for this treatment.
Verified August 2017 by Children's Hospital Medical Center, Cincinnati
Sponsor:
ClinicalTrials.gov Identifier:
NCT01983722
First Posted: November 14, 2013
Last Update Posted: August 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
Expanded access to Stiripentol for patients with Dravet Syndrome.

Condition Intervention
Dravet Syndrome Drug: Stiripentol

Study Type: Expanded Access     What is Expanded Access?
Official Title: Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Detailed Description:
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 6 months and older
  • Diagnosis of Dravet Syndrome with intractable seizures

Exclusion Criteria:

  • Hypersensitivity to the active substance or to any of the excipients
  • Past history of psychoses in the form of episodes of delirium
  • Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN
  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): NCT01983722


Contacts
Contact: David N Franz, MD 513-636-4222

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Contact: David N Franz, MD    513-636-4222      
Principal Investigator: David N Franz, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01983722     History of Changes
Other Study ID Numbers: 2013-5518
First Submitted: November 7, 2013
First Posted: November 14, 2013
Last Update Posted: August 23, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stiripentol
Anticonvulsants