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

NCT06131580 | Unknown Phase 4

• 2 other identifiers: MP-02-2024-11788278454
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Endogenous Cushing Syndrome

Keywords

Endogenous Cushing syndrome; Cushing syndrome; osilodrostat; long term safety; Canada

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse/serious adverse events

  To evaluate long term safety

  up to 2 years

Secondary Outcomes (1)

• Percentage of patients with clinical benefit

  up to 2 years

Study Arms (1)

Participant Group/Arm

OTHER

Other: osilodrostat open label, with patients receiving same dose as provided in the parent study

Drug: Intervention/Treatment

Interventions

Intervention/Treatment DRUG

Drug: osilodrostat \- osilodrostat, in the form of film coated tablets for oral administration, in the following tablet strengths: 1mg, 5mg, 10mg. Each strength has unique tablet size, colour and imprint.

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• RECORDATI GROUP: collaborator

Study Sites (3)

University of Alberta Hospital - Alberta Diabetes Institute

Edmonton, Alberta, T6G 2E1, Canada

Location

Nova Scotia Health

Halifax, Nova Scotia, B3H 1V7, Canada

Location

CHUS Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Cushing Syndrome

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• André Lacroix, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center (four sites in Canada), open-label study to evaluate the long term safety of osilodrostat in 7 patients currently being treated in a Global Recordati-sponsored study (LCI699C2X01B) and who are judged by their doctor as benefiting from the current study treatment. The study is expected to remain open for approximately 2 years from EOT (end of trial) visit for each patient in roll-over study. Patients will continue to be treated in this study until they are no longer benefiting from their osilodrostat treatment as judged by the Investigator, until one of the protocoldefined discontinuation criteria is met. Additionally, Company (RRD) agrees to provide osilodrostat for investigational use through the study until patients can transition to commercially available and reimbursed drug in patients' province, as long as there is a path, as determine by RRD Canada Inc., to reimbursement.

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: October 24, 2023
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)