6 completed, 2 terminated, 1 active not recruiting. 4 Phase 3, 3 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Terminated 2, Active not recruiting 1, Completed 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 2 |
Follow ampreloxetine: new trials by email Literature Review of ampreloxetine trials Research Report on ampreloxetine
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 |
|---|---|---|---|---|---|---|
| Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy Ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy | Phase 3 | Active not recruiting | Theravance Biopharma | 102 | 2023-06-27 | 2025-09-05 |
| Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855 Ampreloxetine - Symptomatic Neurogenic Orthostatic Hypertension, nOH | Phase 1 | Completed | Theravance Biopharma | 31 | 2020-01-13 | 2021-09-08 |
| Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine - Symptomatic Neurogenic Orthostatic Hypotension | Phase 3 | Terminated | Theravance Biopharma | 110 | 2019-09-19 | 2022-11-30 |
| Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension, MSA | Phase 3 | Terminated | Theravance Biopharma | 203 | 2019-02-22 | 2023-01-20 |
| Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure ampreloxetine, Placebo - Symptomatic Neurogenic Orthostatic Hypotension | Phase 3 | Completed | Theravance Biopharma | 195 | 2019-01-24 | 2022-09-14 |
| Drug-Drug Interaction (DDI) Study for TD-9855 TD-9855, Fluvoxamine, Itraconazole - Drug Drug Interaction (DDI) | Phase 1 | Completed | Theravance Biopharma | 41 | 2018-02-28 | 2021-01-14 |
| TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) TD-9855, Placebo - Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension | Phase 2 | Completed | Theravance Biopharma | 34 | 2017-09-09 | 2022-09-26 |
| TD-9855 Mass Balance Study TD-9855 - ADHD, Fibromyalgia | Phase 1 | Completed | Theravance Biopharma | 6 | 2013-10-01 | 2021-01-19 |
| A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) TD-9855, Placebo - Attention-Deficit/Hyperactivity Disorder, ADHD | Phase 2 | Completed | Theravance Biopharma | 295 | 2011-12-01 | 2022-04-04 |
Parkinson Disease (4) · Pure Autonomic Failure (4) · Dizziness (3) · Hypotension (3) · Hypotension, Orthostatic (3) · Syncope (3) · Attention Deficit Disorder with Hyperactivity (2) · Multiple System Atrophy (2) · Parkinsonian Disorders (2) · Fibromyalgia (1) · Multiple system atrophy (MSA) with orthostatic hypotension (1) · Shy-Drager Syndrome (1) · Smoking (1)
United States (9) · Australia (4) · Austria (4) · Canada (4) · Denmark (4) · Estonia (4) · France (4) · Germany (4) · Israel (4) · Italy (4) · New Zealand (4) · Poland (4) · Portugal (4) · Spain (4) · United Kingdom (4)
PMID 42475649, PMID 32856281, PMID 33782836, PMID 34657222, PMID 38654484
2018 (2), 2019 (1)