A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)

RECORDATI GROUP1 site in 1 country103 target enrollmentJanuary 16, 2023

ConditionsCushing's Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cushing's Syndrome
Sponsor: RECORDATI GROUP
Enrollment: 103
Locations: 1
Primary Endpoint: Effectiveness of Osilodrostat
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.

Registry

clinicaltrials.gov

Start Date

January 16, 2023

End Date

October 30, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

RECORDATI GROUP

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines.
•Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.

Exclusion Criteria

•Patients who participated in a clinical trial anytime during the study period.
•Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

Outcomes

Primary Outcomes

Effectiveness of Osilodrostat

Time Frame: at week 12

Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)

Secondary Outcomes

Long-term Effects of Osilodrostat on Composite Cortisol Measure(At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72)
Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)(at weeks 18, 24, 36, 48, 60, and 72)
Long Term Effects of Osilodrostat on Morning Serum Cortisol(At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72)