Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance |
| Ongoing | 4 | 200 | Europe | SABRIL SACHETS, SYNACTHEN DEPOT, SOLUBLE PREDNISOLONE TABLETS, SABRIL SACHETS, SYNACTHEN DEPOT, SOLUBLE PREDNISOLONE TABLETS | Royal United Hospital Bath NHS Trust, , Castang Foundation, NIHR, Bath Unit for Research in Paediatrics, Bronner/Bender Stiftung | Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subsequent epilepsy and neuro-development. There is a high risk of underlying neurological disease that independently causes delayed development and other seizure disorders. There is a high risk of a poor outcome even when there is no other detectable underlying neurological disorder. | | | | |
| Ongoing | 2 | 30 | Europe | Mabthera Infusion, Solu-Medrone, Synacthen Depot, Rituximab, Methylprednisolone, Tetracosactide acetate, Mabthera infusion, Solu-Medrone, Synacthen Depot, Mabthera infusion, Solu-Medrone, Synacthen Depot | Newcastle upon Tyne Hospitals NHS Foundation Trust, Medical Research Council | Autoimmune Addison\'s disease: autoimmune primary adrenal insufficiency | | | | |
| Terminated | 2 | 46 | Europe | Tetracosactide (Synacthène®), placebo saline (0.9% NaCl) | Hospices Civils de Lyon | Post-dural Puncture Headache | 11/22 | 11/22 | | |
| Recruiting | 2 | 12 | Europe | nasal Tetracosactide, cosyntropin, Synacthen, IV tetracosactide, synacthen | Sheffield Children's NHS Foundation Trust | Adrenal Suppression | 12/25 | 12/25 | | |
2012-003241-15: A study to develop a non-invasive version of the diagnostic test of the body's ability to produce enough stress hormone. |
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| Not yet recruiting | 1 | 258 | Europe | 100mcg tetracosactide (in a 1:1 mix with chitosan), 500 mcg tetracosactide, 500 mcg tetracosactide (in a mix 1:1 with chitosan), 1 mcg Synacthen, Nasal spray, solution, Suspension for injection, Synacthen | Sheffield Children's NHS Foundation Trust | In stages 1+2 of the study healthy volunteers will be used to determine the bioequivalence of nasal Synacthen with 1 microgram of intravenous synacthen. Stage 3 will use healthy children to establish normal ranges for the adrenal response to a low-dose synacthen test. In stage 4 adrenal function in asthmatic individuals on inhaled corticosteroids will be studied., Inability to produce the stress hormone, cortisol, is known as adrenal insufficiency. It can cause serious illness and even death. Inhaled steroids taken for asthma can cause adrenal insufficiency., Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | | | | |
NCT03142893: Hormonal Mechanisms of Sleep Restriction - Axis Study |
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| Active, not recruiting | 1 | 80 | US | Ketoconazole Pill, Nizoral, Ganirelix, Dexamethasone, Dexamethasone Injection, Cosyntropin Injectable Product, Recombinant Human Luteinizing Hormone, Luveris, Hydrocortisone Injection, solu-cortef, Gonadorelin, Lutrepulse, Corticorelin, Acthrel, Placebo oral capsule, Saline Solution, Saline Solution for Injection | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Sleep Restriction | 10/20 | 03/25 | | |
NCT04037605: Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women |
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| Active, not recruiting | 1 | 5 | US | Ketoconazole Pill (also known as nizoral), Ganirelix, Dexamethasone Pill, Dexamethasone injection, Cosyntropin Injectable Product, Recombinant Human Luteinizing Hormone (also known as luveris), Hydrocortisone Injection (also known as solu-cortef), Gonadorelin (also known as Lutrepulse), Corticorelin (also known as Acthrel), Placebo oral tablet, Saline Solution, Saline solution for injection | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Sleep Restriction | 07/22 | 07/24 | | |
NCT04546126: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4) |
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| Recruiting | 1 | 24 | US | Dexamethasone (Group 2), Cosyntropin (Group 3), PET/CT Scan with FNP-59 | Benjamin Viglianti | Radiotracer, Hypertension, Cholesterol | 12/25 | 12/25 | | |
NCT03905603: Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS |
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| Recruiting | 1 | 144 | US | ACTH, Cosyntropin, rhCG, Ovidrel | University of Virginia | Polycystic Ovary Syndrome | 04/26 | 05/26 | | |
| Active, not recruiting | N/A | 23 | US | Cosyntropin, ACTH, Placebo, Normal Saline | Brigham and Women's Hospital, Beth Israel Deaconess Medical Center | Autonomic Nervous System, Baroreflex, Stress, Physiological | 10/16 | 12/23 | | |
NCT01421797: Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation |
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| Active, not recruiting | N/A | 84 | US | Dexamethasone, Cortrosyn, ACTH | University of Virginia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego | Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity | 08/24 | 12/24 | | |
NCT04642391: Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis |
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| Completed | N/A | 76 | US | Cosyntropin | University of Virginia, American Association for the Study of Liver Diseases | Cirrhosis, Adrenal Insufficiency | 06/23 | 06/24 | | |