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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05544058
Other study ID # STIRUS (STP228)
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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