6 completed, 2 terminated, 1 unknown. 3 Not applicable, 3 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 3 | Completed 2, Terminated 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 1 | Completed 1 |
Follow Cysteamine Bitartrate: new trials by email Literature Review of Cysteamine Bitartrate trials Research Report on Cysteamine Bitartrate
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 |
|---|---|---|---|---|---|---|
| PK and PD Study of NPI-001 and Cysteamine Bitartrate Cysteamine Bitartrate, N-Acetylcysteine Amide - Cystinosis | Phase 1 / Phase 2 | Completed | Nacuity Pharmaceuticals, Inc. | 8 | 2023-10-29 | 2026-10-13 |
| Observational Study to Assess the Quality of Life in Nephropathic Cystinosis Patients Cysteamine Bitartrate - Nephropathic Cystinosis | Unknown | Chiesi SA/NV | 31 | 2020-07-31 | 2021-11-29 | |
| Cysteamine for Asthma Cysteamine Bitartrate, Placebo Oral Tablet - Asthma | Phase 1 | Completed | Children's Hospital Medical Center, Cincinnati | 60 | 2019-06-18 | 2021-05-06 |
| A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease Cysteamine Bitartrate - Mitochondrial Diseases | Phase 2 | Terminated | Amgen | 22 | 2015-05-19 | 2024-12-27 |
| Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease Cysteamine Bitartrate - Inherited Mitochondrial Disease, Including Leigh Syndrome | Phase 2 | Completed | Amgen | 36 | 2014-05-01 | 2024-12-27 |
| Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in Cystinosis RP103, Cystagon® - Cystinosis | Phase 3 | Completed | Amgen | 41 | 2013-01-31 | 2024-12-27 |
| A Cohort of Patients With Cystinosis : Compliance to Cysteamine and Neurological Complications Cysteamine bitartrate - Cystinosis | Not applicable | Completed | Hospices Civils de Lyon | 65 | 2011-12-01 | 2025-12-19 |
| Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™ Cysteamine bitartrate - Cystinosis, Nephropathic Cystinosis | Not applicable | Completed | University of California, San Diego | 8 | 2011-09-01 | 2013-10-09 |
| Cysteamine Therapy for Major Depressive Disorder cysteamine bitartrate - Major Depressive Disorder | Not applicable | Terminated | Icahn School of Medicine at Mount Sinai | 3 | 2008-07-01 | 2017-04-07 |
Cystinosis (5) · Epilepsies, Myoclonic (2) · Leigh Disease (2) · Mitochondrial Encephalomyopathies (2) · Ophthalmoplegia, Chronic Progressive External (2) · Optic Atrophy, Hereditary, Leber (2) · Acidosis, Lactic (1) · Asthma (1) · Depression (1) · Depressive Disorder, Major (1) · Lysosomal Storage Diseases (1) · Metabolic Diseases (1) · Metabolism, Inborn Errors (1) · Mitochondrial Diseases (1) · Patient Compliance (1)
Amgen (3) · Chiesi SA/NV (1) · Children's Hospital Medical Center, Cincinnati (1) · Hospices Civils de Lyon (1) · Icahn School of Medicine at Mount Sinai (1) · Nacuity Pharmaceuticals, Inc. (1) · University of California, San Diego (1)
United States (6) · Belgium (2) · France (2) · Australia (1) · Italy (1) · Netherlands (1) · United Kingdom (1)
Cochat Pierre, PUPH (1) · Gurjit K Khurana Hershey, MD, PhD (1) · Hugh McCarthy, PhD, FRACP (1) · James Murrough, MD (1) · Ranjan Dohil, M.D. (1)