LINC7: Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- Mean Urinary Free Cortisol (mUFC) [12 weeks]
Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)
Secondary Outcome Measures
- Morning serum cortisol [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Change from baseline
- Mean Urinary Free Cortisol (mUFC) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Change from baseline
- Body Mass Index (BMI) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Electrocardiogram (ECG) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Co-morbidities [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Blood Pressure [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Sodium [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Potassium [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Calcium [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- CO2 [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Glucose Levels [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Glycated haemoglobin (HBA1c) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Plasma Adrenocorticotropic hormone (ACTH) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Serum 11-Deoxycortisol [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Plasma 11-Deoxycorticosterone [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Plasma Aldosterone [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Plasma Renin [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Total Serum Testosterone or oestradiol (per patient sex) [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Serum LH [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
- Serum FSH [At Weeks 4, 8, 12, 20, 28, 36 of treatment and every additional 12 weeks of treatment until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.]
Actual and percentage change from Baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.
Exclusion Criteria:
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Patients who participated in a clinical trial anytime during the study period.
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Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RECORDATI GROUP
Investigators
- Study Director: Alberto M PEDRONCELLI, MD, RECORDATI GROUP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCI699-RECAG-NI-0596