Suffering from Parkinson’s Disease, Multiple System Atrophy, or Pure Autonomic Failure?
- Do You Often Feel Dizzy, Lightheaded, Feel Like You Might Faint or “Black Out”?
- Do Your Symptoms Appear When You Stand Up or Have Been Standing For Some Time, and Improve When You Sit down or Lie Down?
You may be eligibile for an important clinical trial to study the long-term effectiveness of an FDA approved drug!
WHAT IS NEUROGENIC ORTHOSTATIC HYPOTENSION?
Neurogenic orthostatic hypotension (or NOH) is low blood pressure (hypotension) that occurs upon standing (orthostatic). This can affect people with certain neurologic conditions, including:
- Parkinson’s disease (PD)
- Multiple system atrophy (MSA)
- Pure autonomic failure (PAF)
- Non-Diabetic Autonomic Neuropathy (NDAN)
THOSE SUFFERING FROM NOH MAY EXPERIENCE SYMPTOMS SUCH AS:
- Dizziness, lightheadedness, feeling faint or feeling as though the individual might black out
- Problems with vision (blurring, seeing spots,
tunnel vision, etc.) - Weakness
- Fatigue
- Trouble concentrating
- Head/neck discomfort (often described as coat-hanger pain)
For many with NOH, these symptoms are persistent and are often disabling because they interfere with everyday activities like standing and walking.
WHO CAN PARTICIPATE IN THIS CLINICAL TRIAL?
To participate in this clinical trial you must meet certain criteria, including:
- At least 18 years of age
- Have NOH associated with PD, MSA, PAF, DBH
- Do not have a diagnosis of hypertension (high blood pressure) that requires treatment with medications to lower your blood pressure
- Do not have a history of myocardial infarction (heart attack) or stroke within the past two years
- Do not have a history of cancer in the last two years
- Do not have congestive heart failure
Individuals currently taking NORTHERA® prescribed by their doctor are eligible to participate.
QUALIFIED STUDY PARTICIPANTS WILL:
- Attend up to 15 visits at the trial site and participate in 3 visits via telephone. The study will last up to a maximum of 36 weeks
- Receive study-related medical exams and study drug throughout the study at no cost.
- Complete questionnaires about their nOH symptoms during site visits
- Provide blood draws and urine samples for laboratory tests
WHAT DRUG IS BEING STUDIED IN THIS CLINICAL TRIAL?
In 2014, the U.S. Food and Drug Administration (FDA) approved the study drug (NORTHERA® also known as droxidopa) for, “the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic OH caused by…Parkinson’s disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been demonstrated. The continued effectiveness of NORTHERA should be assessed periodically.” The purpose of the current trial is to assess the effectiveness of the study drug to treat symptoms of NOH over a longer period of time.
All participants will receive the study drug for up to 16 weeks during the “open-label” portions of the study. This will help your study doctor determine your optimal dose of study drug. Participants will then receive either the study drug or a matching placebo during the 12-week, “double-blind” portion of the trial (a placebo is a pill that contains no active drug;“double-blind” means that neither you nor the study doctor will know if you are taking the study drug or placebo).
Innovative Research is giving the community an opportunity to sign up for this clinical research study . If you would like further information about this clinical research study, please fill out the contact form and a member of our team will contact you shortly.
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ONLINE CONTACT
Fill out the contact form below and we will contact you regarding participating in this trial opportunity.
What is the Next Step?
If interested, contact us to learn more about this study. Our medical professionals will be happy to answer all of your questions about participation.
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Dr’s Trevino and Little are thorough attentive and concerned. Innovative Research of West Florida have some great studies you can involve yourself in if are looking for solutions to some of your medical questions such as COPD and others. They will take great care of you and the staff is very attentive and considerate.
Our staff is here to answer your questions about clinical trials opportunities. These clinical trials are only open for enrollment for limited times so make sure to contact us.
A clinical research study tests the safety and efficacy of an investigation medicine or treatment in a population of volunteers. Every medical discovery/breakthrough goes through the clinical trial process, so potential participants like you play a very important role in advancing medicine for present and future generations.
The study drug is an investigation product. You may or may not benefit from the study drug.
Protecting the health and safety of people who take part in clinical trials is the highest priority for clinical researchers. All clinical trials must follow strict federal guidelines on how volunteer must be treated throughout the entire study process.
You have the right to leave a clinical trial at anytime and for any reason. If you decide to leave a trial, talk to your doctor first. You will want to know how leaving the trial may affect your health and what other treatment options may be available.
