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

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Brief Title

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

Official Title

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

Brief Summary

      Expanded access to Stiripentol for patients with Dravet Syndrome.
    

Detailed Description

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


Study Type

Expanded Access




Condition

Dravet Syndrome

Intervention

Stiripentol


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility 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
      

Gender

All

Ages

6 Months - N/A


Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01983722

Organization ID

2013-5518


Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

, , 


Verification Date

July 2019