Ampreloxetine (DrugBank: Ampreloxetine)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 13 |
| 17 | Multiple system atrophy | 13 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003941-41-AT (EUCTR) | 05/03/2020 | 19/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 2 | EUCTR2018-003941-41-PT (EUCTR) | 03/02/2020 | 21/08/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 3 | EUCTR2018-003289-15-DE (EUCTR) | 28/01/2020 | 08/02/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany | ||
| 4 | EUCTR2018-003289-15-PT (EUCTR) | 13/01/2020 | 21/08/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 5 | EUCTR2018-003289-15-BG (EUCTR) | 10/10/2019 | 24/07/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2018-003941-41-BG (EUCTR) | 10/10/2019 | 26/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 7 | EUCTR2018-003941-41-PL (EUCTR) | 23/08/2019 | 03/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 8 | EUCTR2018-003941-41-ES (EUCTR) | 13/08/2019 | 11/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 9 | EUCTR2018-003941-41-GB (EUCTR) | 09/08/2019 | 16/05/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 10 | EUCTR2018-003289-15-PL (EUCTR) | 19/07/2019 | 07/05/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine chydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2018-003289-15-DK (EUCTR) | 02/07/2019 | 14/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 12 | EUCTR2018-003289-15-AT (EUCTR) | 15/05/2019 | 22/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 13 | EUCTR2018-003289-15-GB (EUCTR) | 08/05/2019 | 28/12/2018 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled,Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003941-41-AT (EUCTR) | 05/03/2020 | 19/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 2 | EUCTR2018-003941-41-PT (EUCTR) | 03/02/2020 | 21/08/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 3 | EUCTR2018-003289-15-DE (EUCTR) | 28/01/2020 | 08/02/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany | ||
| 4 | EUCTR2018-003289-15-PT (EUCTR) | 13/01/2020 | 21/08/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 5 | EUCTR2018-003941-41-BG (EUCTR) | 10/10/2019 | 26/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2018-003289-15-BG (EUCTR) | 10/10/2019 | 24/07/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 7 | EUCTR2018-003941-41-PL (EUCTR) | 23/08/2019 | 03/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 8 | EUCTR2018-003941-41-ES (EUCTR) | 13/08/2019 | 11/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 9 | EUCTR2018-003941-41-GB (EUCTR) | 09/08/2019 | 16/05/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 10 | EUCTR2018-003289-15-PL (EUCTR) | 19/07/2019 | 07/05/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine chydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2018-003289-15-DK (EUCTR) | 02/07/2019 | 14/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
| 12 | EUCTR2018-003289-15-AT (EUCTR) | 15/05/2019 | 22/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 13 | EUCTR2018-003289-15-GB (EUCTR) | 08/05/2019 | 28/12/2018 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled,Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Sequoia study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand |