CompletedNot Applicable

Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome

France103 participantsStarted 2023-01-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Effectiveness of Osilodrostat

Timeframe: at week 12

Trial details

NCT IDNCT05633953

SponsorRECORDATI GROUP

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-09-30

Results submitted2024-09-26

View on ClinicalTrials.gov More Cushing's Syndrome trials