N/A
N=103
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Cushing's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05633953 ↗Enrolled (actual)
103
Serious AEs
50.5%
Results posted
Feb 2025
Primary outcome: Primary: Effectiveness of Osilodrostat — 23 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Osilodrostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RECORDATI GROUP
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Osilodrostat |
23 | — |
| SECONDARY Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) |
7; 12; 6; 6; 6; 6 | — |
| SECONDARY Long Term Effects of Osilodrostat on Morning Serum Cortisol |
18; 19; 6; 22; 10; 16 | — |
| SECONDARY Long-term Effects of Osilodrostat on Composite Cortisol Measure |
30; 30; 11; 35; 16; 23 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT05633953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.