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

Cushing's Syndrome Clinical Trial

— LINC7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633953
• Other study ID #: LCI699-RECAG-NI-0596
• Status: Completed
• Start date: January 16, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2024
• Source: RECORDATI GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

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

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.

Related Conditions & MeSH terms

• Cushing Syndrome
• Cushing's Syndrome
• Syndrome

Intervention

Drug:
• Osilodrostat
oral administration

Locations

Country	Name	City	State
France	Hôpital Haut-Lévèque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
RECORDATI GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Urinary Free Cortisol (mUFC)	Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) = upper limit of normal (ULN)	12 weeks
Secondary	Mean Urinary Free Cortisol (mUFC)	Proportion of patients with Mean Urinary Free Cortisol (mUFC) = upper limit of normal (ULN)	At Weeks 24, 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.
Secondary	Morning serum cortisol	Change from baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Mean Urinary Free Cortisol (mUFC)	Change from baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Body Mass Index (BMI)	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Electrocardiogram (ECG)	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Co-morbidities	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Blood Pressure	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Sodium	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Potassium	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Calcium	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	CO2	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Glucose Levels	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Glycated haemoglobin (HBA1c)	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Plasma Adrenocorticotropic hormone (ACTH)	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Serum 11-Deoxycortisol	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Plasma 11-Deoxycorticosterone	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Plasma Aldosterone	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Plasma Renin	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Total Serum Testosterone or oestradiol (per patient sex)	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Serum LH	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.
Secondary	Serum FSH	Actual and percentage change from Baseline	At Weeks 4, 8, 12, 18, 24, 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.