Retrospective non-interventional study of stiripentol use in Dravet patients in the USA (Retrospective US Study - STP228)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107006
• EU PAS number:
  EUPAS107005
• Study ID:
  107006
• Official title and acronym:
  Retrospective non-interventional study of stiripentol use in Dravet patients in the USA (Retrospective US Study - STP228)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective, non-interventional, observational, multicentre chart review study to be conducted in patients who have a diagnosis of Dravet syndrome and received stiripentol for a minimum of 3 months. The goal of the study is to understand the management of Dravet patients who received stiripentol in the United States of America after the drug was made available. US sites where investigators are treating or have treated patients with Dravet syndrome will be selected, and investigators will be neurologists and epileptologists who have initiated stiripentol therapy in Dravet patients since 21-Aug-2018. This study will aim to collect data from 100 patients records from approximately 10 sites in the US.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Multiple centres: 10 centres involved in the study

Study timelines

Date when funding contract was signed

Actual: 08/03/2022

Study start date

Actual: 09/05/2022

Data analysis start date

Planned: 01/10/2023

Date of final study report

Planned: 01/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BIOCODEX GENTILLY

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable