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

NCT ID: NCT05544058

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2024-06-28

Brief Summary

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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

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Conditions

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Dravet Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Retrospective study

Retrospective study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* NA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocodex

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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STIRUS (STP228)

Identifier Type: -

Identifier Source: org_study_id

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