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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dravet Syndrome Brain Diseases Central Nervous System Diseases Epilepsies, Myoclonic Epilepsy Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo clinic

Rochester, Minnesota, 55905, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

retrospective study

Other

Retrospective study

Primary outcomes

management of the Dravet syndrome

Time frame: through study completion, an average of 1 year

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

Secondary outcomes

Better detection of the Dravet syndrome

Time frame: through study completion, an average of 1 year

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

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 16, 2022
Registry last updated: Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed