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

Last updated: January 16, 2025
Sponsor: RECORDATI GROUP
Overall Status: Completed

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Cushing's Disease

Treatment

Osilodrostat

Clinical Study ID

NCT05633953
LCI699-RECAG-NI-0596
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., anaetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, orectopic adrenocorticotropic hormone secretion). Patients should have acontemporaneously documented diagnosis of CS as per effective guidelines.

  2. Patients treated with osilodrostat between April 2019 and study start date as partof ATU programme or commercialisation.

Exclusion

Exclusion Criteria:

  1. Patients who participated in a clinical trial anytime during the study period.

  2. Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

Study Design

Total Participants: 103
Treatment Group(s): 1
Primary Treatment: Osilodrostat
Phase:
Study Start date:
January 16, 2023
Estimated Completion Date:
October 30, 2023

Connect with a study center

  • Hôpital Haut-Lévèque

    Pessac, 33604
    France

    Site Not Available

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