Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA

Dravet Syndrome Clinical Trial

Official title:

Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544058
• Other study ID #: STIRUS (STP228)
• Status: Recruiting
• Start date: April 27, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2022
• Source: Biocodex
• Contact: Roxane NOËL, PharmD
• Phone: +33 1 44 86 75 79
• Email: r.noel[@]biocodex.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study aims to collect data regarding the history of the disease, previous and current treatments, and the clinical status of Dravet patients during the 3 months prior to stiripentol initiation, the first 3 months on stiripentol and the last 3 months on stiripentol (irrespective of stiripentol discontinuation).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2023
• Est. primary completion date: May 23, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with Dravet syndrome
• Treated with stiripentol for a minimum of 3 months in routine practice

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Dravet Syndrome
• Epilepsies, Myoclonic

Intervention

Other:
• Retrospective study
Retrospective study

Locations

Country	Name	City	State
United States	Mayo clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biocodex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	management of the Dravet syndrome	Patient Information History of the Disease Clinical status of the patient during the 3 months preceding stiripentol treatment initiation Clinical status of the patient at stiripentol initiation Clinical status of the patient during the first 3 months of stiripentol treatment Clinical status of the patient during the last 3 months of stiripentol treatment Evolution on stiripentol	through study completion, an average of 1 year
Secondary	Better detection of the Dravet syndrome	Patient Information History of the Disease Clinical status of the patient during the 3 months preceding stiripentol treatment initiation Clinical status of the patient at stiripentol initiation Clinical status of the patient during the first 3 months of stiripentol treatment Clinical status of the patient during the last 3 months of stiripentol treatment Evolution on stiripentol	through study completion, an average of 1 year