Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

NCT05382156 · tracked via the Priya Life Science USA tracker

Sponsor

RECORDATI GROUP

Phase

Observational

Started

2022-06-13

Last updated

2025-11-20

Condition(s) studied

Endogenous Cushing's Syndrome

Investigational drug(s) / intervention(s)

Osilodrostat

Osilodrostat: oral administration of Osilodrostat tablets at different doses according to patient's need

Study summary

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Written informed consent obtained prior to registration of any patient data * Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening. Exclusion Criteria: * Patients with exogenous CS * Patients with Pseudo CS * Patients participating in an interventional clinical trial with an investigational drug.

Primary outcome measure(s)

Incidence of osilodrostat-related adverse events and serious adverse events — 3 years of treatment with osilodrostat
Number of participants with Adverse Events and Serious Adverse Events

Trial sites (43)

Facility	City	Region
Barrow Neurological Institute	Phoenix	Arizona
Emory University School	Atlanta	Georgia
Northwestern University	Chicago	Illinois
Indiana University Schl-med	Indianapolis	Indiana
St Elizabeth Physicians	Covington	Kentucky
Massachusetts General Hospital	Boston	Massachusetts
University of Michigan	Ann Arbor	Michigan
Mayo Clinic - Rochester	Rochester	Minnesota
Washington University School of Medicine	St Louis	Missouri
NYU Grossman School of Medicine	New York	New York
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York	New York	New York
Endocrinology Research Associates, Inc.	Columbus	Ohio
Oregon Health And Science University	Portland	Oregon
University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
Froedtert Hospital	Milwaukee	Wisconsin
Hôpital Haut-Lévêque	Bordeaux	France
Hospices Civiles de Lyon	Bron	France
CHU de Grenoble site Nord	Grenoble	France
Groupement Hospitalier Sud - Hôpital Bicêtre	Le Kremlin-Bicêtre	France
Hopital Claude Huriez - CHRU Lille	Lille	France
Hopital de la Conception - APHM	Marseille	France
Hôpital de Brabois	Nancy	France
CHU de Nantes-Hopital Laennec	Nantes	France
Hôpital Cochin	Paris	France
Hopital Larrey	Toulouse	France
Charité Universitaetsmedizin Berlin	Berlin	Germany
Medicover Berlin-Mitte MVZ	Berlin	Germany
Medicover Köln	Cologne	Germany
Universitaet Bielefeld - Klinikum Bielefeld - Mitte	Düsseldorf	Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet	Frankfurt	Germany
Endokrinologikum Frankfurt	Frankfurt	Germany
Amedes Experts	Hamburg	Germany
Medicover Neuroendokrinologie	Munich	Germany
Ludwig-Maximilians University of Munich	Munich	Germany
Medicover MVZ Oldenburg	Oldenburg	Germany
Universitaetsklinikum Wuerzburg	Würzburg	Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona	Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Ospedaliera Universitaria "Federico II"	Naples	Italy
Policlinico Umberto I	Roma	Italy

+ 3 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05382156 on ClinicalTrials.gov ↗ ← All trials in the USA