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

NCT05544058 | Completed

• 1 other identifier: STIRUS (STP228)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Dravet Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Better detection of the Dravet syndrome

  through study completion, an average of 1 year

Interventions

Retrospective study OTHER

Retrospective study

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with dravet syndrome and reated with stiripentol for a minimum of 3 months in routine practice

You may qualify if:

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

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

Mayo clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 16, 2022
• Study Start: April 27, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)