The purpose of this study, called MOVE-PD, is to investigate how individuals with Parkinson's disease (PD) and chronic constipation (CC) respond to RM-131 as compared to placebo. The study will look at how well RM-131 affects the frequency of spontaneous bowel movements over a 14-day period. The study will also evaluate the safety and tolerability of the study drug and evaluate whether the study drug relieves the uncomfortable GI symptoms related to chronic constipation in patients who are unsatisfied with other therapies they have tried for constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
University of Southern California
Los Angeles, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Florida Ctr for Movement Disorders & Neurorestoration
Gainesville, Florida, United States
Emory University, Wesley Woods Health Center
Atlanta, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
University of Iowa Hospitals, Movement Disorders Div, Dept of Neurology
Iowa City, Iowa, United States
Michigan State University
East Lansing, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Atlantic Neuroscience
Summit, New Jersey, United States
University of Rochester
Rochester, New York, United States
...and 3 more locations
Investigate the effects of treatment with RM-131 for 14 days on the frequency of spontaneous bowel movements (SBMs) when administered to patients with Parkinson's Disease (PD) and Chronic Constipation (CC)
Time frame: Screening through Day 28
Evaluate the safety and tolerability of multiple doses of RM-131 when administered to patients with PD and CC
Time frame: Screening through Day 28
Effect of RM-131 on stool frequency as measured by complete spontaneous bowel movements, stool consistency, straining, completeness of evacuation, abdominal pain, and global patient reported outcomes of severity of constipation and overall relief.
Time frame: Screening through Day 28
Assess symptoms of Parkinson's disease using the Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Screening through Day 28
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