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

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ClinicalTrials.gov Identifier: NCT01983722
Expanded Access Status : Available
First Posted : November 14, 2013
Last Update Posted : July 30, 2018
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


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

Locations
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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

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01983722     History of Changes
Other Study ID Numbers: 2013-5518
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Syndrome
Rett Syndrome
Epileptic Syndromes
Epilepsies, Myoclonic
Spasms, Infantile
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Stiripentol
Anticonvulsants