NCT05382156

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

A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. 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

• Endogenous Cushing's Syndrome

Interventions

Type	Name	Description
DRUG	Osilodrostat	oral administration of Osilodrostat tablets at different doses according to patient's need

Timeline

• Start date: 2022-06-13
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2022-05-19
• Last updated: 2025-11-20

Locations

43 sites across 5 countries: United States, France, Germany, Italy, Netherlands

Regulatory

• FDA-regulated drug study