18 completed. 18 Phase 2, 7 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 18 |
| Phase 3 | 7 | Completed 7 |
| Phase 1 | 2 | Completed 2 |
Follow Adrenal Insufficiency: new trials by email Literature Review of Adrenal Insufficiency trials Research Report on Adrenal Insufficiency
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency Chronocort, Plenadren - Primary Adrenal Insufficiency | Phase 2 | Completed | Neurocrine UK Limited | 58 | 2021-11-23 | 2026-09-14 |
| Plasma Exchange With Albumin in AMN Patients Albumin solution - Adrenomyeloneuropathy, Adrenoleukodystrophy | Phase 2 / Phase 3 | Completed | Pujol, Aurora, M.D. | 5 | 2020-03-09 | 2022-09-22 |
| Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation Thiotepa--single daily dose, Thiotepa--escalated dose - Bone Marrow Failure Syndrome, Thalassemia | Phase 1 / Phase 2 | Completed | University of Florida | 6 | 2018-06-15 | 2023-09-15 |
| A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients Leriglitazone, Placebo - Adrenoleukodystrophy | Phase 2 / Phase 3 | Completed | Minoryx Therapeutics, S.L. | 116 | 2017-12-08 | 2026-10-28 |
| Vaginal Prednisone Administration for Prevention of Adrenal Crisis 100mg prednisone suppository - Adrenal Insufficiency | Phase 2 | Completed | Wuerzburg University Hospital | 12 | 2017-01-01 | 2017-06-20 |
| Effect of Pioglitazone Administered to Patients With Adrenomyeloneuropathy Pioglitazone - Adrenomyeloneuropathy, X-linked Adrenoleukodystrophy | Phase 2 | Completed | Pujol, Aurora, M.D. | 18 | 2016-01-01 | 2019-09-10 |
| MD1003-AMN MD1003 in Adrenomyeloneuropathy MD1003 100 mg capsule, Placebo - Adrenomyeloneuropathy, Adrenoleukodystrophy | Phase 2 / Phase 3 | Completed | MedDay Pharmaceuticals SA | 67 | 2014-10-01 | 2017-10-09 |
| Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia Solu-Cortef, Cortef - Addison Disease, Adrenal Hyperplasia Congenital | Phase 1 / Phase 2 | Completed | Haukeland University Hospital | 8 | 2014-03-27 | 2024-06-07 |
| A Study of the Efficacy and Safety of Hematopoietic Stem Cells Transduced With Lenti-D Lentiviral Vector for the Treatment of Cerebral Adrenoleukodystrophy (CALD) Lenti-D Drug Product (eli-cel) - Cerebral Adrenoleukodystrophy (CALD) | Phase 2 / Phase 3 | Completed | Genetix Biotherapeutics Inc. | 32 | 2013-08-21 | 2022-04-25 |
| Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia Hydrocortisone (Solucortef), Insulin pump (Medtronic) - Adrenal Insufficiency, Excess Androgen | Phase 2 | Completed | National Institutes of Health Clinical Center (CC) | 8 | 2013-05-06 | 2017-12-22 |
| Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH Hydrocortisone Modified Release Capsules - Endocrine Disease, Adrenal Insufficiency | Phase 2 | Completed | Neurocrine UK Limited | 16 | 2012-12-01 | 2026-10-02 |
| Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency Hydrocortisone intramuscular first, Hydrocortisone subcutaneously first - Primary Adrenal Insufficiency | Phase 2 | Completed | Bruno Allolio | 12 | 2011-11-01 | 2012-08-01 |
| A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants N-acetylcysteine, lipoic acid, vitamin E - Adrenomyeloneuropathy | Phase 2 | Completed | Pujol, Aurora, M.D. | 13 | 2011-09-01 | 2019-03-11 |
| Glucocorticoid Treatment in Addison's Disease Solu-Cortef (hydrocortisone), Cortef (hydrocortisone) - Addison's Disease | Phase 2 / Phase 3 | Completed | Haukeland University Hospital | 33 | 2010-02-01 | 2013-03-20 |
| Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Campath-1H, Cyclophosphamide, Busulfan - Mucopolysaccharidosis, Hurler Syndrome | Phase 2 | Completed | Masonic Cancer Center, University of Minnesota | 46 | 2009-12-01 | 2018-02-05 |
| Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency hydrocortisone (modified release), oral tablet 20 and 5 mg, Hydrocortisone, oral tablet, 10 mg - Adrenal Insufficiency | Phase 2 / Phase 3 | Completed | Shire | 64 | 2007-08-21 | 2020-11-24 |
| HSCT for High Risk Inherited Inborn Errors Clofarabine, Total body Irradiation, Melphalan - Adrenoleukodystrophy, Metachromatic Leukodystrophy | Phase 2 | Completed | Masonic Cancer Center, University of Minnesota | 38 | 2006-09-01 | 2019-07-11 |
| Stem Cell Transplant for Inborn Errors of Metabolism Stem Cell Transplant, Busulfan, Cyclophosphamide, Antithymocyte Globulin - Adrenoleukodystrophy, Metachromatic Leukodystrophy | Phase 2 / Phase 3 | Completed | Masonic Cancer Center, University of Minnesota | 135 | 1995-01-01 | 2017-12-28 |
Adrenoleukodystrophy (10) · Addison Disease (6) · Adrenal Hyperplasia, Congenital (3) · Leukodystrophy, Globoid Cell (3) · Leukodystrophy, Metachromatic (3) · Fucosidosis (2) · Gangliosidosis, GM1 (2) · Mucopolysaccharidosis I (2) · Sandhoff Disease (2) · Tay-Sachs Disease (2) · Wolman Disease (2) · Anemia, Diamond-Blackfan (1) · Anemia, Hemolytic (1) · Anemia, Sickle Cell (1)
Adrenal Gland Diseases (18) · Endocrine System Diseases (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Genetic Diseases, Inborn (13) · Metabolic Diseases (13) · Nutritional and Metabolic Diseases (13) · Metabolism, Inborn Errors (12) · Brain Diseases (10) · Brain Diseases, Metabolic (10) · Brain Diseases, Metabolic, Inborn (10) · Central Nervous System Diseases (10) · Demyelinating Diseases (10) · Genetic Diseases, X-Linked (10) · Hereditary Central Nervous System Demyelinating Diseases (10)
Hydrocortisone (5) · Alemtuzumab (2) · Busulfan (2) · Cyclophosphamide (2) · Stem Cell Transplantation (2) · hydrocortisone hemisuccinate (2) · Acetylcysteine (1) · Antilymphocyte Serum (1) · Biotin (1) · Bone Marrow Transplantation (1) · Clofarabine (1) · Cyclosporine (1) · Hematopoietic Stem Cell Transplantation (1) · Hydroxyurea (1) · Melphalan (1)
Masonic Cancer Center, University of Minnesota (3) · Pujol, Aurora, M.D. (3) · Haukeland University Hospital (2) · Neurocrine UK Limited (2) · Bruno Allolio (1) · Genetix Biotherapeutics Inc. (1) · MedDay Pharmaceuticals SA (1) · Minoryx Therapeutics, S.L. (1) · National Institutes of Health Clinical Center (CC) (1) · Shire (1) · University of Florida (1) · Wuerzburg University Hospital (1)
United States (8) · Germany (5) · Spain (5) · France (3) · United Kingdom (3) · Norway (2) · Argentina (1) · Australia (1) · Hungary (1) · Italy (1) · Netherlands (1) · Sweden (1)
Paul Orchard, MD (4) · Adrian Thrasher, MD, PhD (1) · Anna G Nilsson, MD, PhD (1) · Biljana Horn, MD (1) · Christine Duncan, MD (1) · David Williams, MD (1) · Deborah P Merke, BS, MS, MD (1) · Deborah P Merke, M.D. (1) · Florian Eichler, MD (1) · Frederic Sedel, MD (1) · Hernan Amartino, MD (1) · Jakob Sieker, MD. (1) · Jorn-Sven Kuhl, MD (1) · Katerina Simunkova, MD, PhD (1)
PMID 21586746, PMID 23672956, PMID 25494662, PMID 27680873, PMID 28976817, PMID 30003563, PMID 31077039, PMID 33236103, PMID 35778568, PMID 36681445, PMID 37172949, PMID 39383458, PMID 39383459, PMID 41552007
2009 (1)