Adrenal Insufficiency Clinical Trial
Official title:
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
NCT number | NCT06430528 |
Other study ID # | HUM00246263 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | August 2027 |
The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Endogenous Cushing syndrome, either following surgery or not candidates for surgery - Under consideration to receive osilodrostat as part of their clinical care - Able to provide informed consent. Exclusion Criteria: - Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer). - A history of hypersensitivity to osilodrostat or therapies of a similar chemical class. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Recordati Rare Diseases |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase) | based on evidence of hypotension (systolic BP <90 mmHg) and/or hypoglycemia (glucose <45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy | Through phase 1, approximately 24 weeks | |
Secondary | Correlation between AM cortisol and 11OHA4 measurements | compare biomarkers measured by mass spectrometry. This may be calculated Upon 12 participants completing phase 1 or at the end of the study, whichever comes first. | Up to end of study, approximately 48 weeks | |
Secondary | Adrenal insufficiency episodes during Phase 2 (maintenance) | based on evidence of hypotension (systolic BP <90 mmHg) and/or hypoglycemia (glucose <45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy | Up to end of phase 2 (approximately 48 weeks) | |
Secondary | Frequency of cortisol withdrawal symptoms | Based on patient-reported outcomes | Up to end of phase 2 (approximately 48 weeks) | |
Secondary | Change in weight | Based on clinic measurements | Baseline, end of phase 2 (approximately 48 weeks) | |
Secondary | Change in diastolic blood pressure | Based on clinic measurements | Baseline, end of phase 2 (approximately 48 weeks) | |
Secondary | Change in systolic blood pressure | Based on clinic measurements | Baseline, end of phase 2 (approximately 48 weeks) | |
Secondary | Change in HgbA1c | Based on clinical laboratory measurements | Baseline, end of phase 2 (approximately 48 weeks) | |
Secondary | Change in number of concomitant medications | Based on clinic notes, total number of medications used to treat Cushing syndrome comorbidities | Baseline, end of phase 2 (approximately 48 weeks) | |
Secondary | Adrenal Insufficiency Assessment Questionnaire scores | Custom questionnaire for adrenal insufficiency- 4 Likert questions with scores ranging from 4-20. Higher scores indicate worse symptoms. | Up to end of study, approximately 48 weeks | |
Secondary | RAND Short Form (SF)-36 scores | The 36-Item Short Form Health Survey (SF-36) is standard RAND form used clinically. It is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 with higher scores indicating a better Health-related Quality of Life. | Up to end of study, approximately 48 weeks | |
Secondary | Ease of titration | Investigators' judgment (1-5 scale) | Up to end of phase 1 (approximately 48 weeks) |
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