Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05633953
Other study ID # LCI699-RECAG-NI-0596
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Completed NCT02468193 - Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome Phase 2
Recruiting NCT00457587 - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma
Completed NCT00006278 - Study of Cushing's Syndrome Not Related to ACTH Production N/A
Completed NCT00361777 - Diagnostic Performance of Screening Tests for Cushing s Syndrome
Completed NCT03606408 - Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 Phase 2
Completed NCT02663609 - Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Recruiting NCT01504555 - Does Serum-DXM Increase Diagnostic Accuracy of the Overnight DXM Suppression Test in the Work-up of Cushing's Syndrome? Phase 3
Active, not recruiting NCT00004343 - Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome N/A
Completed NCT02922257 - Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery
Completed NCT01371565 - Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome Phase 3
Terminated NCT00422201 - Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion Phase 2
Completed NCT00001180 - Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency N/A
Completed NCT02804750 - Study to Evaluate CORT125134 in Participants With Cushing's Syndrome Phase 2
Completed NCT00936741 - An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome Phase 3
Recruiting NCT00004334 - Study of Depression, Peptides, and Steroids in Cushing's Syndrome N/A
Completed NCT03817840 - Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease
Completed NCT01959711 - Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy Phase 4
Completed NCT02889224 - In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man N/A
Terminated NCT00796783 - A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia N/A
Recruiting NCT02019706 - Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome Phase 2