[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cushings-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cushings-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100552341","phase-2-a-trial-of-lu-ag13909-in-adult-participants-with-cushings-disease-100552341",false,"NCT06471829","A Trial of Lu AG13909 in Adult Participants With Cushing's Disease","A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease","BalanCeD","Inclusion Criteria:\n\n* The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines\n* Morning plasma ACTH levels \\> lower limit of normal (LLN) and\n* Evidence of a pituitary origin of the excess ACTH:\n\n  i. Either MRI confirmation of pituitary adenoma \\>6 millimeters (mm), or ii. inferior petrosal sinus gradient \\>2, or iii. histopathology confirmation of ACTH-secreting tumour\n* The participant has a 24-hour UFC \\>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).\n* Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the safety laboratory tests.\n* For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.\n\nExclusion Criteria:\n\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.\n* The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if enrolled, in the opinion of the investigator.\n* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.\n* The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.\n* The participant has severe CD per investigator judgement; among others, this could be participants with:\n\n  i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events\n* The participant had pituitary surgery \\\u003C3 month prior to screening.\n* The participant had pituitary radiotherapy within the last 10 years.\n\nOther protocol-defined criteria apply.","ALL","18 Years","70 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about\n\n1. the effect of Lu AG13909 on cortisol levels.\n2. the safety and tolerability of Lu AG13909.\n3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).",[28],"Cushing's Disease","RECRUITING","2026-06-11",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":33},"2024-06-19",{"date":37,"type":22},"2027-10-31",{"name":39,"class":40},"H. Lundbeck A\u002FS","INDUSTRY",27,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100406221","ddavp-for-pituitary-adenoma-100406221","NCT04569591","DDAVP for Pituitary Adenoma","Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Subjects aged 8 or older with biochemical evidence of Cushing s disease and a clinical MRI pituitary neuroradiology result of negative or possible adenoma (e.g. \"no tumor\" or \"possible tumor\")\n2. MRI of the pituitary gland with and without contrast obtained within 9 months of screening\n3. For newly diagnosed Cushing s disease cases, IPSS is required.\n4. Ability to undergo PET-imaging without general anesthesia\n5. Ability to provide informed consent for study participation (parents or guardians in the case of minors)\n6. Clinical diagnosis of Cushing s disease based on documented medical records\n7. Surgical candidate for and subject agrees to resection of ACTH producing pituitary adenoma within 24 weeks of PET-imaging\n8. Normal liver function as evidenced by liver enzyme tests completed within 14 days before injection of radiopharmaceutical: SGOT, SGPT \\\u003C= 5 x upper limit of normal; bilirubin \\\u003C= 2 x upper limit of normal\n9. Tolerance of a previous infusion of DDAVP, including as part of workup and diagnosis of Cushing's disease\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current pregnancy or lactation\n2. Glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73 m\\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation.\n3. Hyponatremia (serum sodium below 135 mmol\u002FL)\n4. Current diagnosis of angina, significant coronary artery disease, congestive heart failure, or SIADH due to risk of fluid overload and\u002For hyponatremia.\n5. Uncontrolled hypertension (blood pressure \\>150\u002F95 mmHg) due to risk of further increase if fluid overload occurs.\n6. Uncontrolled, severe hypotension (sustained blood pressure \\\u003C90\u002F60), or symptomatic hypotension.\n7. Current use of any of the following medications:\n\n   * Vasopressors: phenylephrine, dopamine and vasopressin\n   * Drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs) within 4 days of testing, loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide), chlorpromazine, chlorpropamide, cisplatin, opiate agonists within 48 hours of testing, and\u002For vincristine.\n   * Drugs that interfere with DDAVP duration of action or potency: carbamazepine, lamotrigine, and\u002For tolvaptan\n8. Habitual or psychogenic polydipsia, due to increased risk of hyponatremia\n9. History of Type IIB von Willebrand s disease due to risk for thrombosis.\n10. Elevated blood glucose level above 200 mg\u002FdL on the day of the scan prior to FDG administration.\n11. Known intolerance to DDAVP\n\nINCLUSION OF VULNERABLE PARTICIPANTS:\n\n* Children: Children age 8 and older are included in this protocol. More than half of the subjects with CD requiring transsphenoidal surgery at the NIH are children. The knowledge gained by the use of DDAVP PET imaging in children with MR-invisible tumors will provide generalizable knowledge in the treatment of CD in this population. Children under the age of 8 usually require anesthesia for a PET scan, which involves greater risk. Therefore, children under the age of 8 will be excluded from participation.\n* Pregnant or lactating women: Pregnant and lactating women will be excluded from participation. The PET radiopharmaceutical used in this study can be harmful to a developing fetus. Therefore women who are able to become pregnant will have a pregnancy test performed within 24 hours before PET imaging. Individuals will not be able to participate in PET scanning if the pregnancy test results positive.","8 Years","99 Years",{"count":52,"type":22},22,[54],"NA","This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for PET-imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo FDG PET-imaging with DDAVP stimulation. Intravenous FDG will be given approximately four hours following DDAVP administration. Within 12 weeks after completion of the FDG high-resolution PET scan, patients will undergo surgical resection of the pituitary adenoma. Surgical and histological confirmation of adenoma location will be noted. All images will be read independently by neuroradiologists blinded to clinical and histopathological outcomes. The diagnostic and localization accuracy of PET-imaging will be assessed by comparing the PET findings with histopathology.",[28,57],"Pituitary Adenoma",[59,60,61],"Corticotropinoma","Pituitary Microadenoma","Acthrel","2026-04-08",{"date":64,"type":33},"2026-04-09",{"date":66,"type":33},"2026-03-09",{"date":68,"type":22},"2028-02-26",{"name":70,"class":71},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100313771","collecting-information-about-treatment-results-for-patients-with-cushings-syndrome-100313771","NCT03364803","Collecting Information About Treatment Results for Patients With Cushing's Syndrome","Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study","Inclusion Criteria:\n\n* Age 14 or older\n* Active or treated overt Cushing's (due to pituitary, ectopic, or adrenal tumor), mild adrenal Cushing's syndrome (MACS), or a silent corticotroph tumor\n* The diagnosis of CS or MACS will be made by the PI, based on the below Endocrine Society guidelines, the patient's clinical presentation, and the PI's judgment.\n\n  * Diagnostic criteria for ACTH-dependent Cushing's are according to the Endocrine Society and European Society of Endocrinology guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol \\> 5 ug\u002FdL after 1 mg overnight of classic 2-day low dose test) and a pituitary lesion on MRI (in the case of pituitary Cushing's). If patient does not have any of these results, pathology of ACTH tumor may confirm presence of disease.\n  * Diagnostic criterion for MACS is according to the European Society of Endocrinology guidelines: Classic dexamethasone suppression testing for CS (morning cortisol \\>1.8 µg\u002FdL after 1 mg overnight) and the presence of an adrenal adenoma.\n* Silent corticotroph tumors will be defined by surgical pathology demonstrating positivity for ACTH, in the absence of clinical and biochemical features of Cushing's syndrome.\n* In lieu of MRI, surgical, or laboratory reports, physician's assessment note including mention of results will also be used as source for eligibility purposes.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of iatrogenic Cushing's.","14 Years",{"count":82,"type":22},300,"OBSERVATIONAL","The purpose of this study is to follow participants with Cushing's syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.",[28,86,87],"Cushing Syndrome","Cushing Disease",[86,28,87,89,90],"17-592","Memorial Sloan Kettering Cancer Center","2025-10-22",{"date":93,"type":33},"2025-10-23",{"date":95,"type":33},"2017-11-28",{"date":97,"type":22},"2026-11-28",{"name":90,"class":99},"OTHER",7]