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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05544058
Enrollment
100
Registered
2022-09-16
Start date
2022-04-27
Completion date
2024-06-28
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dravet Syndrome

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).

Interventions

Retrospective study

Sponsors

Biocodex
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
management of the Dravet syndromethrough study completion, an average of 1 yearPatient 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

MeasureTime frameDescription
Better detection of the Dravet syndromethrough study completion, an average of 1 yearPatient 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026