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

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.
 
ClinicalTrials.gov Identifier: NCT01983722
Expanded Access Status : Approved for marketing
First Posted : November 14, 2013
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Expanded access to Stiripentol for patients with Dravet Syndrome.

Condition or disease Intervention/treatment
Dravet Syndrome Drug: Stiripentol

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

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




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
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

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


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01983722    
Other Study ID Numbers: 2013-5518
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Epilepsies, Myoclonic
Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Stiripentol
Anticonvulsants