UnknownPhase 4

Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome

Canada7 participantsStarted 2023-10-24

Plain-language summary

The purpose of this study is to continue the evaluation of long-term safety of osilodrostat in 7 Canadian patients who have already received osilodrostat treatment in a previous Global Recordati-sponsored roll-over study and who, based on investigators' judgement, will continue benefiting with its administration.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patient is currently participating in a Global Recordati-sponsored roll-over study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
✓. The patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
✓. Patient has demonstrated compliance, as assessed by the Investigator, with the parent roll-over study protocol requirements.
✓. Willingness and ability to comply with scheduled visits and treatment plans.
✓. Written informed consent obtained prior to enrolling into the study

Exclusion criteria

✕. Patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over Recordati-sponsored study.
✕. New patients not previously enrolled in parent roll-over Recordatisponsored study.
✕. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory evaluation.

What they're measuring

Number of participants with adverse/serious adverse events

Timeframe: up to 2 years

Trial details

NCT IDNCT06131580

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-24

View on ClinicalTrials.gov More Endogenous Cushing Syndrome trials