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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

ISS-CA-2023 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.Check my eligibility

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.See study design

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.

ISS-CA-2023 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse/serious adverse events

Secondary outcome measures

Percentage of patients with clinical benefit

ISS-CA-2023 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,630 Total Patients Enrolled

Recordati Rare DiseasesIndustry Sponsor

10 Previous Clinical Trials

460 Total Patients Enrolled

André Lacroix, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to join the experimental protocol?

"Patients who wish to qualify for this medical trial should have a diagnosis of cushing syndrome and an age between 18-75. A total of 7 individuals are planned to be enrolled in the study."

Answered by AI

Does this research study accept individuals of more advanced age?

"This trial is open to individuals aged 18-75. 387 studies are available for those younger than 18, and 1067 research opportunities exist for patients over the age of 65."

Answered by AI

Is Participant Group/Arm deemed a secure option for people?

"The safety of Participant Group/Arm was rated as a 3, given its status as an approved Phase 4 trial."

Answered by AI

Is this study presently recruiting participants?

"According to clinicaltrials.gov, this particular medical trial does not currently need any more participants. The study was first posted on October 24th 2023 and last updated November 9th 2023; however there are over 1500 other trials actively seeking enrolment at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06131580.

All > Cushings Syndrome