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

Expanded access is currently available for this treatment.
Verified September 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01983722
First received: November 7, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

Expanded access to Stiripentol for patients with Dravet Syndrome. This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.


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:

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01983722     History of Changes
Other Study ID Numbers: 2013-5518
Study First Received: November 7, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014