Come walk with us down the
CYPRESS path

Taking another critical step for potential treatment of nOH in patients with MSA

We are evaluating an investigational therapy and seeking patients for a Phase 3 clinical study

Have you been diagnosed with multiple system atrophy (MSA) and have symptoms associated with neurogenic orthostatic hypotension (nOH)? If so, you may be able to participate in this study.

Taking another critical step for potential treatment of nOH in patients with MSA

We are evaluating an investigational therapy and seeking patients for a Phase 3 clinical study

Have you been diagnosed with multiple system atrophy (MSA) and have symptoms associated with neurogenic orthostatic hypotension (nOH)? If so, you may be able to participate in this study.

WHAT TO EXPECT

We are researching the investigational drug (ampreloxetine) because we believe it may reduce nOH symptoms that interfere with daily activity in patients with MSA based on prior clinical trial results. We are running the Phase 3 CYPRESS study to confirm whether the investigational drug is effective and safe in treating nOH and providing symptom relief in patients with MSA, and to learn about any unwanted side effects.

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Study Highlights
  • Once-daily, single tablet
  • All participants receive investigational drug during the open-label period, followed by treatment with either placebo or investigational drug
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Duration of Study
  • 20-week treatment period
  • Participants who remain in the study will receive the investigational drug for up to 2 years as part of a long-term extension of the study
Study Visits
  • Simple evaluations (similar to regular checkups with questionnaires)
  • Only 9 visits in the treatment period

Ampreloxetine is not currently approved by any health agency for use in treating nOH in patients with MSA.

THE CYPRESS PATH

STUDY DESIGNS

Open-label means both the healthcare providers and the patients are aware of the drug or treatment being given.

Double-blinded means that neither you nor your study doctor will know if you are taking the study drug or placebo.

WHO CAN TAKE PART IN THE CYPRESS STUDY?

Man and Woman
You may be eligible to take part in the CYPRESS study if you:
  • Have a diagnosis of possible or probable multiple system atrophy (MSA) of the Parkinsonian or cerebellar subtype
  • Have symptoms related to neurogenic orthostatic hypotension (nOH)
  • Are 30 years of age or older

You will also need to meet additional criteria to qualify. A study doctor can explain these to you.

If someone has symptomatic nOH, it means they are experiencing symptoms such as:
  • Vision problems
  • Weakness
  • Fatigue
  • Trouble concentrating
  • Head/neck discomfort
  • Dizziness
  • Feeling light-headed
  • Feeling faint
  • Feeling like blacking out
Man and Woman

HOW TO PARTICIPATE IN THE CYPRESS STUDY

We know how important it is to make clinical trial participation as easy as possible, and we are committed to supporting participants with travel logistics and expenses necessary to attend in-clinic visits.

You can enroll in the study at one of our open clinical sites.

You can learn more about the CYPRESS study by:

Man and Doctor talking

CYPRESS STUDY SITES

Site Locations

Scottsdale, Arizona, USA, 85258

Movement Disorders Center of Arizona

Contact: Study Coordinator

Actively Recruiting

La Jolla, California, USA, 92037

UC San Diego Movement Disorder Center

Contact: Jasmin Hernandez

858-246-2533

Jah022@health.ucsd.edu

Actively Recruiting

Fountain Valley, California, USA, 92708

The Parkinson’s and Movement Disorder Institute

Contact: Evan Moreno-Davis

714-378-5021

evan@pmdi.org

Actively Recruiting

Palo Alto, California, USA, 94304

Stanford Neuroscience Health Center

Contact: Study Coordinator

Actively Recruiting

Washington, District of Columbia, USA, 20007

Medstar Georgetown University Hospital

Contact: Luke Lovelace

202-444-1382

ll928@georgetown.edu

Actively Recruiting

Boca Raton, Florida, USA, 33486

Parkinson’s Disease And Movement Disorders Center of Boca Raton

Contact: Study Coordinator

561-392-1818 ext 2

Info@parkinsonscenter.org

Actively Recruiting

Boca Raton, Florida, USA, 33487

SFM Clinical Research, LLC

Contact: Study Coordinator

561-939-0333 

Research@sfneurology.com

Actively Recruiting

Naples, Florida 34105, USA

Aqualane Clinical Research

Contact: Study Coordinator

Actively Recruiting

Tampa, Florida, USA, 33612

University of South Florida Ataxia Research Center

Contact: Julia Tenorio-Ibanez

813-974-5909

juliatenorio@usf.edu

Actively Recruiting

Chicago, Illinois, USA, 60612

Rush University Medical Center

Contact: Study Coordinator

312-563-2900 ext 4

Actively Recruiting

Glenview, Illinois, USA, 60026-1339

Northshore University Health System

Actively Recruiting

Kansas City, Kansas, USA 66160

University of Kansas Medical Center Research Institute, Inc.

Contact: Study Coordinator

913-588-7159

Actively Recruiting

Worcester, Massachusetts, USA, 01655

UMass Chan Medcial School

Contact: Tatiana Hopkins

Actively Recruiting

Farmington Hills, Michigan, USA 48334

Quest Research Institute

Contact: Study Coordinator

248-957-8940

Actively Recruiting

Pontiac, Michigan, USA, 48302

International Medical Clinic PLLC

Contact: Study Coordinator

248-955-9949

clinic@practicure.com

Actively Recruiting

New York, New York, USA, 10032

The Neurological Institute at Columbia University Medical Center

Contact: Study Coordinator

Actively Recruiting

New York, New York, USA, 10016

NYU Langone Health NYU Dysautonomia Center

Contact: Jose Martinez

Actively Recruiting

Cincinnati, Ohio, USA, 45219

University of Cincinnati Medical Center

Contact: Lauren Wingler

513-558-4050

winglelh@ucmail.uc.edu

Actively Recruiting

Nashville, Tennessee, USA, 37232

Vanderbilt University Medical Center

Contact: Bonnie Black

615-343-6862 

bonnie.black@vumc.org

Actively Recruiting

Dallas, Texas, USA, 75390

University of Texas Southwestern Medical Center

Contact: Steve Hopkins

Actively Recruiting

Calgary, Alberta, Canada, T2N 4Z6

University of Calgary – Health Sciences Centre

Contact: Angela-Ji Yao Qi

Actively Recruiting

University of Calgary – Health Sciences Centre

Contact: Rasha Hamzeh

Actively Recruiting

FREQUENTLY ASKED QUESTIONS

A Phase 3 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 investigational drug work or how effective is it compared to other drugs/devices?

This research study is testing an investigational drug (ampreloxetine) compared to placebo in people with MSA and symptomatic nOH. It will help answer the following questions:

  • How effective is ampreloxetine in treating people with MSA and nOH?
  • How safe is ampreloxetine and are there unwanted side effects?

You can talk to a study doctor to find out if you may qualify for the study. Contact us at cypress@theravance.com or by calling +1-855-633-8479.

There is no cost to participate in the CYPRESS study. The investigational drug, 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.

No health insurance is required to participate.

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

The research team at your study site will be able to explain more about what the CYPRESS study will involve, and it is up to you to decide if you want to participate. 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 or may not benefit from the investigational drug (ampreloxetine). It is not known if your condition will get any better; it may get worse. This study is being conducted to learn more about the investigational drug. What we learn may help other MSA patients in the future. 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. You should also discuss this question with your physician.

Please contact us to explore further options; we are committed to supporting participants with travel logistics and expenses necessary to participate in the study.

The clinical study has 9 visits over approximately 20 weeks. If you continue in the (optional) long-term extension study, there are 2 additional visits.

Participants in the CYPRESS study are restricted from participating in other studies in which they receive an investigational drug. Participation in an observational study that does not require interventional treatment (e.g., another study drug from a different trial) is permitted.

The investigational drug (ampreloxetine) was assessed in a study that had a similar design to the CYPRESS study. In that study, in a pre-specified population of participants with MSA, there was a durable and clinically meaningful improvement in their nOH symptoms. The results of this study are available on the Theravance Biopharma website. We are running the Phase 3 CYPRESS study to confirm whether the results of the prior trial are replicable in a larger group of patients.