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

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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

Study Description

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.

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Pyridoxal 5'-phosphate-dependent epilepsy CDKL5 deficiency disorder Genetic epilepsy with febrile seizures plus CHD2 myoclonic encephalopathy

Genetic and Rare Diseases Information Center resources: Dravet Syndrome CDKL5 Deficiency Disorder

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Eligibility Criteria

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

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

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

More Information

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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

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