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Pitt+Me RESTORE Study


STUDY BASICS

Do you experience dizziness or light-headedness or feel like you are going to faint when you stand up? Have you been diagnosed with Parkinson’s disease, multiple system atrophy, pure autonomic failure, non-diabetic autonomic neuropathy, or dopamine beta-hydroxylase deficiency? You may be able to participate in a research study to see if a drug called droxidopa can help. Compensation provided.


STUDY PURPOSE

Neurogenic orthostatic hypotension (NOH) is a rare disorder in which low blood pressure occurs upon standing and causes dizziness, lightheadedness, fainting, and other symptoms. NOH occurs in people with existing neurologic conditions like Parkinson’s disease, multiple system atrophy, pure autonomic failure, non-diabetic autonomic neuropathy, or dopamine beta-hydroxylase deficiency.

The purpose of this study is to find out if taking a study drug called droxidopa (also known by the trade name of NORTHERA™) for an extended time period is safe and effective in people with symptomatic neurogenic orthostatic hypotension (NOH). While droxidopa (NORTHERA™) has been approved in the United States for the treatment of NOH associated with these conditions, the benefits of droxidopa beyond two weeks have not been demonstrated. Since this study extends beyond two weeks, the use of droxidopa in this study is investigational.


COULD THIS STUDY BE RIGHT FOR YOU?

•    Ages 18 and up
•    Diagnosed with symptomatic Neurogenic orthostatic hypotension (NOH) associated with Parkinson’s disease, multiple system atrophy, pure autonomic failure, non-diabetic autonomic neuropathy, or dopamine beta-hydroxylase deficiency


WHAT PARTICIPANTS CAN EXPECT

Total study participation could last up to 36 weeks (9 months) with up to 18study assessments (in-person and over-the-phone). Participation involves review of medical records, physical exam, questionnaires, electrocardiogram (ECG), and blood draws.

During the first part of the study, all participants will be given droxidopa (NORTHERA™) for up to 16 weeks. Following this, participants who continue in the study will be randomly assigned (like the flip of a coin) to continue taking droxidopa (NORTHERA™), or to receive a placebo for an additional 12 weeks. The placebo looks and tastes just like droxidopa but does not contain any active drug.


IRB:
  30917/38 - RESTORE: A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess Sustained effecTs Of dRoxidopa thErapy

Age Range
AGE:   18 and Up

Duration DURATION:  Up to 9 months
VISITS:  Up to 18

Location LOCATION: 
University of Pittsburgh Department of Neurology – Kaufmann Medical Building
Compensation COMPENSATION: 
Up to $700
Phone Number PHONE NUMBER:
1-866-438-8230
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Phone Number PHONE NUMBER:
1-866-438-8230

MEET THE RESEARCHER


Valerie Suski

Valerie R. Suski, DO, is an assistant professor of neurology at the University of Pittsburgh School of Medicine and Director of the Huntington's Disease Society of America (HDSA) Center of Excellence at UPMC, a multidisciplinary HD clinic that includes social work, physical therapy, occupational therapy, speech therapy, psychiatry, nutrition, and genetic counseling. She is also a member of the Comprehensive Movement Disorders Clinic and the Pittsburgh Institute of Neurodegenerative Diseases. Dr. Suski is very passionate about understanding neurological conditions such as Parkinson’s or Huntington’s disease, as well as other movement disorders. Her research focuses on helping both patients and their families.




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