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NCT01983722 Clinical Trial

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

Dravet Syndrome Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT01983722
Other study ID # 2013-5518
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date July 2019
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

Expanded access to Stiripentol for patients with Dravet Syndrome.

Description:

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

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 6 Months and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stiripentol

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

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