Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome (LINC6)

Recordati

Status: Active, not recruiting

Conditions: Endogenous Cushing's Syndrome

Treatments: Drug: Osilodrostat

Study type: Observational

Funder types: Industry

Identifiers

NCT05382156

LCI699-RECAG-PASS-0572

Details and patient eligibility

About

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

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

206 participants in 1 patient group

Osilodrostat

Description:

Osilodrostat - tablets of 1mg, 5mg, 10mg - based on patients needs - up to 3 years

Treatment:

Drug: Osilodrostat