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| ID | Type | Description | Link |
|---|---|---|---|
| 278454 | Other Identifier | Health Canada |
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| Name | Class |
|---|---|
| RECORDATI GROUP | INDUSTRY |
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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.
There will be no screening period for this study. Eligible subjects can start their treatment with osilodrostat as soon as they are enrolled in the study. The first study visit will be scheduled at the time of the last study visit for the parent study. Subjects must return to the study center at least on a quarterly basis (every 12 weeks ± 2 weeks) for safety and clinical benefit assessments, and resupply of study medication. Drug dispensing and administration information and adverse events will be collected. The subject may return to the clinic at any given time as per standard of care or treating physician recommendation; however, only the quarterly study visits will be recorded in the Case Report Form (CRF). Study medication dispensed will be recorded in the CRF dose administration page.
All adverse events and serious adverse events, including pregnancy, will be collected throughout the study. Subjects will continue to be treated in this roll-over study until they are no longer benefiting from their osilodrostat treatment as judged by the Investigator or until osilodrostat is commercially available or until one of other discontinuation criteria is met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group/Arm | Other | Other: osilodrostat open label, with patients receiving same dose as provided in the parent study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse/serious adverse events | To evaluate long term safety | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical benefit | clinical benefit as assessed by the investigator | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André Lacroix, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital - Alberta Diabetes Institute | Edmonton | Alberta | T6G 2E1 | Canada | ||
| Nova Scotia Health |
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| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
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| Halifax |
| Nova Scotia |
| B3H 1V7 |
| Canada |
| CHUS Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |