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Completed

NCT Number: NCT05633953

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

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.

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Key information

Conditions

Cushing's Syndrome Adrenal Gland Diseases Adrenocortical Hyperfunction Cushing Syndrome Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Haut-Lévèque

Pessac, 33604, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osilodrostat

Drug

oral administration

Primary outcomes

  1. Effectiveness of Osilodrostat

    Time frame: at week 12

    Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)

Secondary outcomes

  1. Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)

    Time frame: at weeks 18, 24, 36, 48, 60, and 72

    Proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN) by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

  2. Long Term Effects of Osilodrostat on Morning Serum Cortisol

    Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

    Proportion of patients with normal measures of morning serum cortisol [≤ upper normal limit (ULN)] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

  3. Long-term Effects of Osilodrostat on Composite Cortisol Measure

    Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

    Proportion of patients with normal response of composite cortisol (salivary cortisol, urinary cortisol and morning serum cortisol) [≤ upper normal limit (ULN)] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

Sponsors and collaborators

Lead sponsor

RECORDATI GROUP

Industry

Registry information

Official study 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)

Acronym: LINC7

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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