If so, we are looking for volunteers to take part in a research study for an investigational medicine called ampreloxetine (also known as TD-9855) to potentially treat symptomatic neurogenic hypotension (nOH).

In people with conditions such as MSA, PD, and PAF the autonomic nervous system may not work as well at regulating your blood pressure. A result of this is that patients experience a sudden drop in blood pressure upon standing.

This can cause symptoms such as dizziness, light-headedness, feeling faint, or feeling like you might black out. These symptoms and drop in blood pressure is called symptomatic neurogenic orthostatic hypotension (nOH).

No health insurance is required to participate. All study-related care will be provided by qualified medical professionals at no cost to you. You may be compensated for your time and travel.

See If You Qualify To see if you might qualify for the REDWOOD Study, please go to www.clinicaltrials.gov for further details, or call us at +1-855-633-8479 or email us at medinfo@theravance.com.

Get started User

The REDWOOD Study

The REDWOOD Study will include participants with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) who, upon standing experience dizziness, light-headedness, feeling faint, or feeling like they might black out due to low blood pressure. It will be conducted at study sites in multiple countries, and in some areas, most of the study can be completed remotely (from your home). All study-related care will be provided by specialty physicians and a dedicated study team.

If you live in the US and qualify for the study, you will be given information to allow you to visit a study clinic in your area to learn more about the study from a study doctor.
Who can take part in the REDWOOD Study?

You may be eligible to take part in the REDWOOD Study if you:

  • are at least 30 years of age
  • have been diagnosed with multiple system atrophy, Parkinson’s disease, or pure autonomic failure
  • upon standing, have symptoms such as dizziness, light-headedness, feeling faint, or feeling like you might black out

About The Study

The REDWOOD Study is evaluating an investigational medicine, taken by mouth, called ampreloxetine (also known as TD-9855), for people with PD, MSA, or PAF who, upon standing, have symptoms such as dizziness, light-headedness, feeling faint, or feeling like they might black out due to a drop in blood pressure. The first 16 weeks of the REDWOOD Study is "open-label" – all participants will receive ampreloxetine. Participants who complete the REDWOOD study may be eligible to enter into an additional ampreloxetine clinical trial.

  • 1
    You may be eligible if you are over the age of 30, have been diagnosed with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF), and upon standing, have symptoms such as dizziness, light-headedness, feeling faint, or feeling like you might black out.
  • 2
    All study-related care is provided at no cost, and health insurance is not required to participate. Participants may also be eligible to receive compensation for their time and travel regardless of their distance from the clinic.
  • 3
    Some participants may be eligible to participate in the study remotely (e.g. from your home), with only 1 required study visit in person at the clinic.
  • 4
    If you qualify and join the study, your participation will last about 6 months and include 11 scheduled study visits or remote interactions with your research staff.

Who can take part in
The REDWOOD Study?

You have been diagnosed with multiple system atrophy, Parkinson’s disease, or pure autonomic failure

You are at least 30 years of age

Upon standing, have symptoms such as dizziness, light-headedness, feeling faint, or feeling like you might black out

 

Frequently Asked Questions

A Clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug or device, such as: Does the treatment work or how effective is it compared to other drugs/devices?

What can you expect from the REDWOOD Study?

If you choose to participate in the REDWOOD Study, at visits, you will undergo general physical examination procedures to assess your wellbeing (e.g. height, weight, blood pressure).

All study-related care is provided at no cost to you. You do not need health insurance to participate.

Participation is entirely voluntary. Even if you decide to take part in this study, you can change your mind about participating at any time.

Participants who complete the REDWOOD Study may be eligible to enter into an additional ampreloxetine clinical trial.

Volunteers who take part in the study may be compensated for travel costs and time in the study. Please discuss this with the study team when they contact you.

There is no cost to participate in the REDWOOD Study. The study medication, study-related tests, assessments, and study visits will be provided at no cost to you and your insurance company. If you decide to take part in the study, you will receive study-related care throughout the study from a team of experienced doctors and nurses.

The research team will be able to explain more about what the REDWOOD Study will involve, and it is up to you to decide if whether or not you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

There are risks and benefits of taking part in any clinical study. For example, your health may be more closely monitored than it would have been otherwise. You may also benefit from taking the investigational drug, though this is not guaranteed. The known risks and benefits of participation are outlined in the informed consent form (ICF) that you must read and sign before you can take part in this study.

We match you to a research center within a close travel distance from your home. If we are not currently running any trials in your area, we will keep you in our database and reach out to you if an ampreloxetine study site in your area becomes available. If you qualify, the study sites can discuss travel arrangements, and compensation is available for study-related travel costs.

You will need to attend the site/research center (in-clinic) for your screening visit as part of the study. For subsequent study visits, you and your doctor can discuss completing those study visits either in the site/research center (in-clinic), or remotely (e.g. your home or residence).

About PD, MSA, or PAF and Symptoms of dizziness, light-headedness, feeling faint, or feeling like you might black out, upon standing.

The nervous system is a complex and sophisticated system that is responsible for regulating and coordinating activities of the body. There are two major divisions of the nervous system, which consists of the central nervous system (the brain and spinal cord), and the peripheral nervous system (peripheral nerves and the autonomic nerves.)

Disorders of the nervous system not only affect the brain and spinal cord, but also may affect the eyes, ears and sensory receptors in the skin, joints and muscles.2 Your autonomic nervous system is also responsible for important body functions, such as controlling your heart rate and blood pressure.

In people with conditions such as multiple system atrophy, Parkinson’s disease, and pure autonomic failure the autonomic nervous system may not work as well at regulating their blood pressure. A result of this is that patients with conditions such as Parkinson’s disease, multiple system atrophy, and pure autonomic failure experience a sudden drop in blood pressure upon standing. This can cause symptoms such as dizziness, light-headedness, feeling faint, or feeling like you might black out. This is called symptomatic neurogenic orthostatic hypotension (nOH).

Other symptoms of symptomatic nOH may include the following:
  • Problems with vision (blurring, seeing spots, tunnel vision, etc.)
  • Weakness
  • Fatigue
  • Trouble Concentrating
  • Head/neck discomfort
The REDWOOD Study

is looking at an investigational drug called ampreloxetine (also known as TD-9855), for people with nervous system conditions who, upon standing, experience dizziness, light-headedness, feeling faint, feeling like they might black out or other symptoms due to a drop in blood pressure.

See If You Qualify To see if you might qualify for the REDWOOD Study, please go to www.clinicaltrials.gov for further details, or call us at +1-855-633-8479 or email us at medinfo@theravance.com.