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

Completed

• Conditions: Dravet Syndrome

• Registration Number: NCT05544058
• Lead Sponsor: Biocodex

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-27
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-16
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• NA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
management of the Dravet syndrome	through study completion, an average of 1 year	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

Secondary Outcome Measures

Name	Time	Method
Better detection of the Dravet syndrome	through study completion, an average of 1 year	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

Trial Locations

Locations (1)

Mayo clinic; 🇺🇸 Rochester, Minnesota, United States