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Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)

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ClinicalTrials.gov Identifier: NCT05633953
Recruitment Status : Completed
First Posted : December 1, 2022
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
RECORDATI GROUP

Tracking Information
First Submitted Date November 16, 2022
First Posted Date December 1, 2022
Last Update Posted Date April 26, 2024
Actual Study Start Date January 16, 2023
Actual Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2022)		 Mean Urinary Free Cortisol (mUFC) [ Time Frame: 12 weeks ]
Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 21, 2023)
  • Mean Urinary Free Cortisol (mUFC) [ Time Frame: 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. ]
    Proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)
  • Morning serum cortisol [ Time Frame: 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. ]
    Change from baseline
  • Mean Urinary Free Cortisol (mUFC) [ Time Frame: 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. ]
    Change from baseline
  • Body Mass Index (BMI) [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Electrocardiogram (ECG) [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Co-morbidities [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Blood Pressure [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Sodium [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Potassium [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Calcium [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • CO2 [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Glucose Levels [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Glycated haemoglobin (HBA1c) [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Plasma Adrenocorticotropic hormone (ACTH) [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Serum 11-Deoxycortisol [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Plasma 11-Deoxycorticosterone [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Plasma Aldosterone [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Plasma Renin [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Total Serum Testosterone or oestradiol (per patient sex) [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Serum LH [ Time Frame: 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. ]
    Actual and percentage change from Baseline
  • Serum FSH [ Time Frame: 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. ]
    Actual and percentage change from Baseline
Original Secondary Outcome Measures
 (submitted: November 30, 2022)
  • Morning serum cortisol [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will consist of patients with non-CD CS. Patients meeting eligibility criteria will be retrospectively identified and included in the study by site investigators based on a review of medical records at site. Site policies and local regulations regarding patient consent (NOL) will be followed. All eligible patients identified at a site between April 2019 and study start date and consenting to be part of the study will be included.
Condition Cushing's Syndrome
Intervention Drug: Osilodrostat
oral administration
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 11, 2023)		 104
Original Estimated Enrollment
 (submitted: November 30, 2022)		 50
Actual Study Completion Date October 30, 2023
Actual Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05633953
Other Study ID Numbers LCI699-RECAG-NI-0596
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party RECORDATI GROUP
Original Responsible Party Same as current
Current Study Sponsor RECORDATI GROUP
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Mario M MALDONADO, MD RECORDATI GROUP
PRS Account RECORDATI GROUP
Verification Date April 2024