Your session is about to expire
← Back to Search
PR001 for Parkinson's Disease
Study Summary
This trial is testing a new drug to treat Parkinson's disease in patients with a pathogenic GBA1 mutation. The study will last 5 years and will evaluate the safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures of the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My weight is between 88 and 242 lbs, and my BMI is between 18 and 34.My weight is between 88 and 242 lbs, and my BMI is between 18 and 34.I have had the pneumococcal and shingles vaccines within the last 10 years.Criterion: You have any of the following conditions or diseases that could interfere with the study, pose a safety risk, or make it difficult for you to follow the study procedures: liver problems, unstable autoimmune disease, uncontrolled diabetes, heart issues, uncontrolled high blood pressure, recent history of certain cancers, recent alcohol or drug abuse, current psychiatric diagnosis that may interfere with study procedures, risk of self-harm, spinal diseases, bleeding problems, recent stroke, recent seizures, active or severe infections, severe allergies, history of certain infections, abnormal lab test results, recent participation in another study with disease-modifying effects on PD, recent gene or cell therapy, recent live vaccinations, recent use of certain medications, contraindications or intolerance to imaging methods, contraindications to anesthesia or sedation, positive urine test for drugs of abuse without prescription, frailty or medical condition that may not be in your best interest to participate in the study.I, or my legal representative, can understand and consent to the study.I agree not to donate sperm during and after the study.I don't have allergies or reasons I can't use corticosteroids or sirolimus, including recent severe osteoporosis, uncontrolled high blood pressure, diabetes, or cholesterol.You need to have a recent test showing you don't have tuberculosis, or get cleared by a doctor if you had a positive test in the past.I have a confirmed GBA1 mutation.I have been diagnosed with Parkinson's Disease.My Parkinson's is in the moderate to severe stage.My Parkinson's is in the moderate to severe stage.I can walk without the help of a walker or wheelchair.My medications, including those for Parkinson's or Gaucher Disease, have been stable for the last 8 weeks.I have a brain condition that is not Parkinson's but could be causing my symptoms.My cognitive test score is below 14.I have someone who can help provide information about my health and abilities for the study.I am up to date with all my cancer screenings as recommended for my age and gender.My MRI shows a significant issue in my spine, neck, or brain that could interfere with certain treatments.I am either not able to have children, or I will use effective birth control during the study.
Frequently Asked Questions
Where can individuals access this clinical trial?
"Enrolment is currently available at 6 clinical sites, including Orlando, Chicago and Philadelphia among several other locations. To reduce your travel burden if you decide to join the trial, it is highly recommended that you select a nearby site."
Have there been previous experiments with PR001 that have yielded results?
"Research into PR001 first began in 1993 at National Institutes of Health Clinical Center, 9000 Rockville Pike. Up to the present day, 1768 medical trials associated with this topic have been completed and 825 are still ongoing; many of these studies taking place in Orlando, Florida."
Is this experiment currently accessible to subjects?
"This medical study is not taking on new patients at this time. It was first posted on March 1st 2020 and most recently updated on July 1st 2022. If you are searching for other studies, there are currently 484 trials involving Parkinson's disease and 825 trials concerning PR001 that have open enrollment positions still available."
How many subjects are participating in the current clinical trial?
"This medical trial is no longer recruiting patients at this time. It was initially posted on March 1st 2020 and last edited July 1st 2022. Those seeking clinical trials for Parkinson's disease can find 484 ongoing studies, while 825 are actively looking for participants of PR001."
For what pathologies is PR001 a recommended remedy?
"PR001 is generally given to patients with scalp problems, but it has also demonstrated success in cases of organ transplantation, thyroiditis and polyangium."
Is the minimum age requirement for participation in this trial 18 years or older?
"The study is seeking participants aged between 35 and 80 years old."
To whom is enrollment in this clinical survey open?
"This clinical trial is targeting 24 persons aged 35 to 80 with a diagnosis of [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease). To be eligible, they must meet the following standards: UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria; Hoehn & Yahr Stage III-IV (in an OFF state); stabilized background medications for at least 8 weeks prior; one pathogenic GBA1 mutation confirmed by the central laboratory; negative MTB test within 1 year preceding screening; reliable study partner/informant willing and able to participate in assessments throughout duration of trial.; nonchildbearing potential women must either have had surgery or be postmenopausal; child"
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Popular Guides
Share this study with friends
Copy Link
Messenger