Clinical trials: Pure Autonomic Failure
Diabetes Mellitus, Hypoglycemia
Mechanisms of Hypoglycemia Associated Autonomic Failure
Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health benefits. However, despite development of insulin analogs, pump/multi-dose treatment and continuous glucose monitoring, maintaining…
- Conditions
- Diabetes Mellitus, Hypoglycemia, Autonomic Failure
- Trial name
- NCT00678145
- Testing
- naloxone, fructose, exercise
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge…
- Conditions
- Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
- Trial name
- NOH304 (NCT01132326)
- Testing
- Droxidopa
- Volunteers
- 350 people
- Sponsor
- Chelsea Therapeutics
Symptomatic Neurogenic Orthostatic Hypotension
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
- Trial name
- OAK (NCT04095793)
- Testing
- ampreloxetine
- Where
- 55 sites in United States, Australia and 16 more
- Volunteers
- 110 people
- Sponsor
- Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.
- Trial name
- SEQUOIA (NCT03750552)
- Testing
- ampreloxetine
- Where
- 125 sites in United States, Australia and 17 more
- Volunteers
- 195 people
- Sponsor
- Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH)…
- Trial name
- RESTORE (NCT02586623)
- Testing
- Droxidopa capsules
- Where
- 168 sites in United States
- Volunteers
- 453 people
- Sponsor
- H. Lundbeck A/S
Hypertension, Pure Autonomic Failure
Nebivolol in the Supine Hypertension of Autonomic Failure
The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine…
- Conditions
- Hypertension, Pure Autonomic Failure, Multiple System Atrophy
- Trial name
- NCT01044693
- Testing
- Nebivolol 5 mg, metoprolol tartrate 50 mg, Sildenafil25 mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vanderbilt University
Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic…
- Conditions
- Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic Failure, Parkinson Disease
- Trial name
- NCT02705755
- Testing
- TD-9855
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Theravance Biopharma
Neurogenic Orthostatic Hypotension, Non-Diabetic Autonomic Neuropathy
Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
The purpose of this study is to assess the durability of effect of Droxidopa in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy…
- Conditions
- Neurogenic Orthostatic Hypotension, Non-Diabetic Autonomic Neuropathy, Multiple System Atrophy, Dopamine Beta Hydroxylase Deficiency
- Trial name
- NOH303 (NCT00738062)
- Testing
- Droxidopa
- Where
- 54 sites in United States, Australia and 2 more
- Volunteers
- 103 people
- Sponsor
- Chelsea Therapeutics
Neurogenic Orthostatic Hypotension
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic hypotension are scarce and not effective. If left untreated, these patients have the highest risk of syncope, falls and fall-related injuries.
- Trial name
- NETAF (NCT02784535)
- Testing
- Atomoxetine
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Vanderbilt University Medical Center
Hypertension, Pure Autonomic Failure
Nitric Oxide and the Autonomic Nervous System
The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels.
- Trial name
- NCT00178919
- Testing
- L-NMMA, Trimethaphan
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Multiple System Atrophy
A Study of Lu AF82422 in Participants With Multiple System Atrophy
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
- Trial name
- AMULET (NCT05104476)
- Testing
- Lu AF82422
- Where
- 19 sites in United States, Japan
- Volunteers
- 64 people
- Sponsor
- H. Lundbeck A/S
Neurogenic Orthostatic Hypotension, Autonomic Failure
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on…
- Conditions
- Neurogenic Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
- Trial name
- NCT04620382
- Testing
- Midodrine, Abdominal compression
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Vanderbilt University Medical Center
Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy, Pure Autonomic Failure
- Trial name
- NCT01927055
- Testing
- Droxidopa
- Where
- 3 sites in United States
- Volunteers
- 61 people
- Sponsor
- Chelsea Therapeutics
Autoimmune Autonomic Ganglionopathy (AAG)
Evaluating the Effectiveness of Intravenous Immunoglobulin Therapy in Autoimmune Autonomic Ganglionopathy
The purpose of the study is to see if administering intravenous immune globulin (IVIG) (putting immune globulin directly into your blood) helps to improve the symptoms of orthostatic hypotension (sudden fall in blood pressure…
- Trial name
- NCT01522235
- Testing
- Double blinded IVIg, Single Blinded IVIg
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Beth Israel Deaconess Medical Center
Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy
A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy…
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Trial name
- NOH301 (NCT00782340)
- Testing
- Droxidopa
- Where
- 21 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Chelsea Therapeutics
Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy…
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Trial name
- NOH302 (NCT00633880)
- Testing
- Droxidopa
- Where
- 54 sites in United States, Australia and 2 more
- Volunteers
- 181 people
- Sponsor
- Chelsea Therapeutics
Symptomatic Neurogenic Orthostatic Hypotension, MSA
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, MSA, Parkinson's Disease (PD), Pure Autonomic Failure (PAF)
- Trial name
- REDWOOD (NCT03829657)
- Testing
- ampreloxetine
- Where
- 82 sites in United States, Australia and 17 more
- Volunteers
- 203 people
- Sponsor
- Theravance Biopharma
Diabetes Mellitus, Type 1, Hypoglycemia
Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)
The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with…
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia, Hypoglycemia Unawareness
- Trial name
- NCT03608163
- Testing
- Naloxone, Diazoxide
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Hypertension, Pure Autonomic Failure
Local Heat Stress in Autonomic Failure Patients With Supine Hypertension
Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing), and at least half of them also have high blood pressure while lying down (supine hypertension).
- Conditions
- Hypertension, Pure Autonomic Failure, Multiple System Atrophy, Autonomic Failure
- Trial name
- NCT02417415
- Testing
- Passive heat stress, Control (non-heating)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Vanderbilt University