Stiripentol in Dravet Syndrome

Dravet Syndrome Clinical Trial

Official title:

Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01533506
• Other study ID #: 12-000690
• Status: No longer available
• Phase: Phase 4
• First received: February 9, 2012
• Last updated: February 26, 2013
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures

Study Design

N/A

Related Conditions & MeSH terms

• Dravet Syndrome
• Epilepsies, Myoclonic
• Syndrome

Intervention

Drug:
• stiripentol
Stiripentol up to 30 mg/kg/day to control seizures

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,