CLINICAL TRIALS PROFILE FOR METYROSINE
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All Clinical Trials for metyrosine
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00581477 ↗ | Treatment of Orthostatic Hypotension | Completed | Vanderbilt University | Phase 3 | 2004-01-01 | The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. This study consists of single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months) trials. |
| NCT00581477 ↗ | Treatment of Orthostatic Hypotension | Completed | Vanderbilt University Medical Center | Phase 3 | 2004-01-01 | The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. This study consists of single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months) trials. |
| NCT01127503 ↗ | Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome | Terminated | Bausch Health Americas, Inc. | Phase 2 | 2010-06-01 | This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS). |
| NCT01127503 ↗ | Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome | Terminated | Valeant Pharmaceuticals International, Inc. | Phase 2 | 2010-06-01 | This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS). |
| NCT03512756 ↗ | A Randomized Phase 2/3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer | Active, not recruiting | Tyme, Inc | Phase 2/Phase 3 | 2018-03-27 | A prospective, open-label phase 2/3 trial in metastatic pancreatic cancer subjects who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1 enrollment complete) In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative was evaluated. (Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 subjects in the second part will be randomized 1:1 either to the SM-88 arm (125 subjects) or Physician's Choice of therapy for the Control Arm (125 subjects). Subjects should have previously received two lines of prior systemic therapy. |
| NCT03778996 ↗ | SM-88 as Maintenance Therapy for Advanced Ewing's Sarcoma Patients and as Salvage Therapy for Sarcoma Patients | Recruiting | Joseph Ahmed Foundation | Phase 2 | 2020-01-03 | The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts: - Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment - Clinically advanced sarcoma patients in the salvage treatment setting Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations. |
| NCT03778996 ↗ | SM-88 as Maintenance Therapy for Advanced Ewing's Sarcoma Patients and as Salvage Therapy for Sarcoma Patients | Recruiting | Tyme, Inc | Phase 2 | 2020-01-03 | The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts: - Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment - Clinically advanced sarcoma patients in the salvage treatment setting Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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