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Corticosteroid

Long-Term Safety Study for Cushing's Syndrome (ISS-CA-2023 Trial)

Phase 4
Waitlist Available
Led By André Lacroix, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial assesses long-term safety of a drug to continue helping 7 Canadian patients.

Who is the study for?
This trial is for Canadian patients with Cushing's Syndrome who have shown good adherence to a previous osilodrostat treatment study, are willing to follow the new study plan, and continue to benefit from osilodrostat as judged by their doctor. It excludes new patients, those discontinued from prior osilodrostat studies, or women who are pregnant or nursing.
What is being tested?
The trial aims to assess the long-term safety of continued use of osilodrostat in seven Canadian patients with endogenous Cushing's Syndrome. These individuals have previously participated in another related study and will keep receiving this medication under investigator supervision.
What are the potential side effects?
While specific side effects aren't listed here, they would typically include any adverse reactions previously observed during the initial roll-over study where participants first received osilodrostat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse/serious adverse events
Secondary study objectives
Percentage of patients with clinical benefit

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participant Group/ArmExperimental Treatment1 Intervention
Other: osilodrostat open label, with patients receiving same dose as provided in the parent study

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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,513 Total Patients Enrolled
Recordati Rare DiseasesIndustry Sponsor
13 Previous Clinical Trials
532 Total Patients Enrolled
1 Trials studying Cushing Syndrome
12 Patients Enrolled for Cushing Syndrome
André Lacroix, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
~3 spots leftby Nov 2025
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