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Desmopressin Test for Cushing Syndrome

Phase 2
Recruiting
Led By Lynnette K Nieman, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-70 years
Patients with possible ACTH-dependent Cushing Syndrome: Evidence of hypercortisolemia, Evidence of normal or increased plasma ACTH (>20 pg/mL)
Must not have
History of angina, significant coronary artery disease, congestive heart failure, or syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Treatment of diabetes insipidus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -5, 0, 15, 30, 45 and 60 minutes
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to improve the desmopressin stimulation test (DesmoST) used to diagnose Cushing syndrome, a condition caused by excess cortisol. The study will focus on the accuracy of

Who is the study for?
This trial is for adults aged 18 to 70 who may have Cushing syndrome (CS), particularly Cushing disease (CD) or ectopic ACTH syndrome (EAS). Healthy volunteers are also needed. Participants with CS will undergo three DesmoSTs, and healthy ones will have four tests spaced days apart.
What is being tested?
The study aims to improve the accuracy of the desmopressin stimulation test in diagnosing ACTH-dependent CS. It involves taking dexamethasone before one of the tests and measuring blood cortisol levels multiple times after administering desmopressin.
What are the potential side effects?
Potential side effects from desmopressin can include headache, nausea, allergic reactions, or low sodium levels in the blood. Dexamethasone might cause increased appetite, mood changes, insomnia or stomach irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have high cortisol levels and normal or high ACTH levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart issues or SIADH.
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I am receiving treatment for diabetes insipidus.
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My blood pressure is not higher than 150/95 mmHg.
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I am currently taking medications like desmopressin or steroids daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-5, 0, 15, 30, 45 and 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and -5, 0, 15, 30, 45 and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ACTH and cortisol responses
Secondary study objectives
Diagnostic accuracy, specificity, sensitivity of cortisol and ACTH measurements in response to desmopressin

Side effects data

From 2012 Phase 3 trial • 395 Patients • NCT01262456
5%
Headache
2%
Hyponatraemia
1%
Osteoarthritis
1%
Acute myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Desmopressin 50 μg Double-Blind
Desmopressin 75 μg Double-Blind
Placebo Double-Blind
Desmopressin 50 μg Double-Blind / 100 μg Open-Label
Desmopressin 75 μg Double-Blind / 100 μg Open-Label
Placebo Double-Blind / Desmopressin 100 μg Open-Label

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Desmopressin 10 mcg Ad-lib fluidExperimental Treatment1 Intervention
Desmopressin 10 mcg Ad-lib fluidHealthy volunteers only
Group II: Desmopressin 10 mcg NPOActive Control1 Intervention
Desmopressin 10 mcg
Group III: Desmopressin NPO 4 mcgActive Control1 Intervention
Desmopressin 4 mcg
Group IV: Dexmopressin 10 mcg NPO + DexamethasoneActive Control2 Interventions
Desmopressin 10 mcgDexamethasone 1 mg pretreatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desmopressin
2010
Completed Phase 4
~3990

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,463 Previous Clinical Trials
4,337,263 Total Patients Enrolled
1 Trials studying Cushing's Syndrome
80 Patients Enrolled for Cushing's Syndrome
Lynnette K Nieman, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
3,887 Total Patients Enrolled
4 Trials studying Cushing's Syndrome
667 Patients Enrolled for Cushing's Syndrome
~93 spots leftby Oct 2028
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