18 completed, 4 terminated, 4 unknown, 3 withdrawn. 30 Phase 2, 8 Phase 3, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 30 | Completed 18, Terminated 4, Unknown 4, Withdrawn 3, Recruiting 1 |
| Phase 3 | 8 | Completed 7, Unknown 1 |
| Phase 1 | 6 | Completed 2, Terminated 2, Unknown 1, Withdrawn 1 |
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 |
|---|---|---|---|---|---|---|
| Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) PXL065 - ALD (Adrenoleukodystrophy) | Phase 2 | Withdrawn | Poxel SA | 2023-09-01 | 2024-12-16 | |
| Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) PXL770 - Adrenomyeloneuropathy | Phase 2 | Withdrawn | Poxel SA | 2023-09-01 | 2024-12-16 | |
| A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN) SBT101 Treatment - AMN, AMN Gene Mutation | Phase 1 / Phase 2 | Terminated | SwanBio Therapeutics, Inc. | 9 | 2022-11-17 | 2026-08-26 |
| 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 |
| Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy Sobetirome (NV1205) - X-Linked Adrenoleukodystrophy | Phase 1 / Phase 2 | Withdrawn | NeuroVia, Inc. | 2018-08-01 | 2019-03-07 | |
| 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 |
| Autologous Hematopoietic Stem Cell Gene Therapy for Metachromatic Leukodystrophy and Adrenoleukodystrophy transduced CD34+ hematopoietic stem cell - Metachromatic Leukodystrophy, Adrenoleukodystrophy | Phase 1 / Phase 2 | Unknown | Shenzhen Second People's Hospital | 50 | 2015-01-01 | 2022-05-31 |
| 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 |
| Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT Hydroxyurea, Alemtuzumab, Fludarabine - Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes | Phase 2 | Recruiting | Paul Szabolcs | 100 | 2014-02-04 | 2025-12-15 |
| 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 |
| Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure Hydrocortisone - Addison Disease | Phase 2 | Unknown | Haukeland University Hospital | 20 | 2013-06-01 | 2013-12-02 |
| 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 |
| Continuous Subcutaneous Hydrocortisone Infusion In Addison's Disease and Type 1 Diabetes Cortef, Solu-cortef - Addison Disease, Type 1 Diabetes | Phase 2 | Terminated | Haukeland University Hospital | 4 | 2013-04-24 | 2024-03-01 |
| 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 |
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Adrenoleukodystrophy (18) · Addison Disease (8) · Leukodystrophy, Metachromatic (6) · Leukodystrophy, Globoid Cell (5) · Mucopolysaccharidosis I (4) · Adrenal Hyperplasia, Congenital (3) · Metabolism, Inborn Errors (3) · Mucopolysaccharidosis II (3) · Sandhoff Disease (3) · Tay-Sachs Disease (3) · alpha-Mannosidosis (3) · Anemia, Diamond-Blackfan (2) · Anemia, Sickle Cell (2) · Fucosidosis (2)
Adrenal Gland Diseases (30) · Endocrine System Diseases (29) · Nutritional and Metabolic Diseases (22) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (21) · Genetic Diseases, Inborn (21) · Metabolic Diseases (21) · Brain Diseases (18) · Central Nervous System Diseases (18) · Genetic Diseases, X-Linked (18) · Intellectual Disability (18) · Metabolism, Inborn Errors (18) · Nervous System Diseases (18) · Neurobehavioral Manifestations (18) · Neurologic Manifestations (18)
Hydrocortisone (9) · Alemtuzumab (3) · Stem Cell Transplantation (3) · hydrocortisone hemisuccinate (3) · Busulfan (2) · Cyclophosphamide (2) · Hydroxyurea (2) · Melphalan (2) · 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-7H-thieno)(2,3-b)pyridin-4-olate potassium (1) · Acetylcysteine (1) · Antilymphocyte Serum (1) · Biotin (1) · Bone Marrow Transplantation (1) · Clofarabine (1) · Cyclosporine (1)
Haukeland University Hospital (4) · Masonic Cancer Center, University of Minnesota (3) · Pujol, Aurora, M.D. (3) · Neurocrine UK Limited (2) · Poxel SA (2) · Bruno Allolio (1) · Genetix Biotherapeutics Inc. (1) · Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (1) · MedDay Pharmaceuticals SA (1) · Minoryx Therapeutics, S.L. (1) · National Institutes of Health Clinical Center (CC) (1) · NeuroVia, Inc. (1) · Paul Szabolcs (1) · Shenzhen Second People's Hospital (1) · Shire (1)
United States (12) · Germany (5) · Spain (5) · France (4) · Norway (4) · United Kingdom (4) · Argentina (2) · Australia (2) · Italy (2) · Netherlands (2) · Brazil (1) · Chile (1) · China (1) · Colombia (1) · Hungary (1)
Paul Orchard, MD (4) · Adrian Thrasher, MD, PhD (1) · Anna G Nilsson, MD, PhD (1) · Biljana Horn, MD (1) · Carlo Alessandria, MD (1) · Christine Duncan, MD (1) · David Williams, MD (1) · Deborah P Merke, BS, MS, MD (1) · Deborah P Merke, M.D. (1) · Eystein Husebye, Professor (1) · Florian Eichler, MD (1) · Frederic Sedel, MD (1) · Gerald V Raymond, M.D. (1) · GuangFu Chen, M.D.,Ph.D (1)
PMID 21586746, PMID 11231629, PMID 11399225, PMID 19892975, PMID 23672956, PMID 23845948, PMID 23966770, PMID 25494662, PMID 27680873, PMID 28976817, PMID 30003563, PMID 31077039, PMID 32634238, PMID 32750127, PMID 33236103, PMID 35778568, PMID 36681445, PMID 37172949, PMID 39383458, PMID 39383459, PMID 41552007
2009 (1)