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New treatment option for Cushing Syndrome
Official title Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
ClinicalTrials.gov ID: NCT06635629
What this study is testing
What is Desmopressin?
Desmopressin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cushing syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18-70 years
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Evidence of acceptable laboratory testing results within four weeks of the first test day, as shown by medical record review:
- Hematocrit at entry \>=33 %
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study, based on medical record review (possible...
- Inability to comply with all study procedures and visits
- Inability of subject to understand or to sign a written informed consent document.
- Known allergy/hypersensitivity to desmopressin.
- Pregnancy or lactation, due to alterations in measured serum cortisol and lack of data on desmopressin safety.
- A history of angina, significant coronary artery disease, congestive heart failure, or syndrome of inappropriate antidiuretic hormone secretion...
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18-70 years
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Evidence of acceptable laboratory testing results within four weeks of the first test day, as shown by medical record review:
- Hematocrit at entry \>=33 %
- Plasma sodium 136-145 mmol/L (unless taking a drug that can cause hyponatremia, see below) eGFR \>=60 ml/min/1.73 sq.m, calculated based on serum creatinine
- For people taking any drug that could worsen hyponatremia, a normal plasma sodium (136-145 mmol/L) must have been obtained within seven days of the first test day. In addition, an individual must meet all the criteria...
- A. Hypercortisolemia as evidenced by physician note or laboratory report: at least one screening modality (1 mg dexamethasone suppression test, 24-hour urinary free cortisol (UFC), bedtime or late night (2200h - 2359h)...
- A. Normal or increased plasma ACTH (\>20 pg/mL) as evidenced by physician note or laboratory report. B. Patients with recurrent ACTH-dependent Cushing Syndrome (previous CD or EAS): 1B. Evidence of previous remission of...
- An individual who meets any of the following criteria will be excluded from participation in this study, based on medical record review (possible Cushing syndrome patients) or a screening visit (healthy volunteers).
- Inability to comply with all study procedures and visits
- Inability of subject to understand or to sign a written informed consent document.
- Known allergy/hypersensitivity to desmopressin.
- Pregnancy or lactation, due to alterations in measured serum cortisol and lack of data on desmopressin safety.
- A history of angina, significant coronary artery disease, congestive heart failure, or syndrome of inappropriate antidiuretic hormone secretion (SIADH), due to risk of fluid overload and/or hyponatremia.
- Uncontrolled hypertension (blood pressure \>150/95 mmHg) at screening and before desmopressin administration, due to risk of further increase if fluid overload occurs
- Any condition that in the opinion of the Investigator would jeopardize the participant s appropriate participation in this study.
- Current daily use of any of the following medications:
- Drug used for the stimulation tests: Desmopressin.
- Drugs that can suppress ACTH and cortisol test responses: Systemic glucocorticoids, including inhaled or topical formulations.
- Vasopressors: phenylephrine, dopamine and vasopressin.
- Drugs that interfere with desmopressin duration of action or potency: carbamazepine, lamotrigine, tolvaptan
- Strong inducers of CYP3A4 (e.g. barbiturates, phenytoin, rifampin, rifabutin, rifapentine, carbamazepine, eslicarbazepine, primidone, cenobamate, Modafinil). Use of St John's wort or nafcillin within 14 days.
- Initiation or dose increase within the past 14 days of drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs), loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide)...
- Chronic enhanced hydration (estimated as \>4 liters) to supplement mealtime fluid intake.
- Any contraindication to intravenous catheter use.
- Previous participation in this protocol.
- History of hemophilia of any type.
- Any hematology or chemistry screening laboratory value drawn at screening that the Investigator determines is clinically significant for exclusion. Condition-specific exclusions will also apply to each subject group as...
- A. Use of medications that block glucocorticoid production (ketoconazole, levoketoconazole, metyrapone, osilodrostat) within the past two weeks, if normal cortisol is achieved. If hypercortisolism persists despite the...
- A. Use of the adrenolytic mitotane at any point, due to its prolonged half-life.
- A. Use of medications that block glucocorticoid action or ACTH release within the past two weeks - mifepristone, cabergoline, octreotide (subcutaneous), pasireotide (subcutaneous), megestrol acetate, other synthetic...
- A. Use of intramuscular long-acting forms of octreotide or pasireotide within the past 4 months.
- A. Treatment of diabetes insipidus. B. Healthy volunteers:
- B. Use of oral, injectable, or inhaled glucocorticoids (unless intermittent, for symptomatic asthma) within the last year. Use of topical non-hydrocortisone containing potent glucocorticoids on more than 36 square...
- B. Hemoglobin A1c \>= 6.5% on screening labs.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.