Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome
NCT ID: NCT05382156
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
206 participants
OBSERVATIONAL
2022-06-13
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
NCT05633953
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
NCT02468193
Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699
NCT03606408
Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome
NCT06131580
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
NCT02310269
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis.
The total number of patients enrolled in this study will be approximately 201. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Osilodrostat
Osilodrostat - tablets of 1mg, 5mg, 10mg - based on patients needs - up to 3 years
Osilodrostat
oral administration of Osilodrostat tablets at different doses according to patient's need
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Osilodrostat
oral administration of Osilodrostat tablets at different doses according to patient's need
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Pseudo CS
* Patients participating in an interventional clinical trial with an investigational drug.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RECORDATI GROUP
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mario Maldonado, MD
Role: STUDY_CHAIR
Recordati AG - Head of Clinical Development
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barrow Neurological Institute
Phoenix, Arizona, United States
Emory University School
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Schl-med
Indianapolis, Indiana, United States
St Elizabeth Physicians
Covington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Grossman School of Medicine
New York, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
Endocrinology Research Associates, Inc.
Columbus, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
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"
Napoli, , Italy
Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Radboud University Nijmegen
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LCI699-RECAG-PASS-0572
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.