Clinical TrialID 5661
Study of Urate Elevation in Parkinson's Disease, Phase 3
NCT02642393
Parkinson's Disease
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5661
- Evidence Id
- 5661
- Core Evidence Id
- 5661
- Source Clinical Trial Id
- 5647
- Herb2 Clinical Trial Id
- HBCT005647
- Nct Id
- NCT02642393
- Title
- Study of Urate Elevation in Parkinson's Disease, Phase 3
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Parkinson's Disease
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
- Intervention
- DRUG: Inosine|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Other
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 298
- Outcome Measure
- Rate of Clinical Decline, The primary outcome of the trial is rate of change in the Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) I-III total score over 24 months estimated from a shared-baseline, random-slopes mixed model, censoring follow-up of subjects after initiation of dopaminergic therapy. Parts I-III of the MDS-UPDRS include ratings of non-motor experiences of daily living, motor experiences of daily living, and a motor examination. The MDS-UPDRS is assessed on a 5-point Likert scale ranging from 0 to 4 where higher scores imply worse symptoms. Parts I-III contain 59 total questions (13 in Part I, 13 in Part II, and 33 in Part III). Total scores for Parts I-III are calculated as simple sums of component items with mean imputation by Part if no more than 1, 2, or 7 items are missing for Parts I through III, respectively. Total scores may range from 0 to 236, with 0 meaning no symptoms and 236 meaning worse symptoms., two years
- Sponsor Collaborator
- Michael Alan Schwarzschild|The Parkinson Study Group|Michael J. Fox Foundation for Parkinson's Research|University of Rochester|National Institute of Neurological Disorders and Stroke (NINDS)
- Funded By
- OTHER
- Location
- University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|Barrow Neurological Institute, Phoenix, Arizona, 85013, United States|Mayo Clinic Arizona, Scottsdale, Arizona, 85259, United States|Banner Sun Health Research Institute, Sun City, Arizona, 85351, United States|University of California San Diego, La Jolla, California, 92093, United States|University of Southern California, Los Angeles, California, 90033, United States|University of California Davis, Sacramento, California, 95817, United States|University of California San Francisco, San Francisco, California, 94143, United States|University of Colorado, Aurora, Colorado, 80045, United States|Rocky Mountain Movement Disorder Center, Englewood, Colorado, 80113, United States|Hartford HealthCare Movement Disorders Center, Vernon, Connecticut, 06066, United States|University of South Florida, Tampa, Florida, 33613, United States|Emory University, Atlanta, Georgia, 30329, United States|Augusta University, Augusta, Georgia, 30912, United States|Northwestern University, Chicago, Illinois, 60611, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|Neurosciences Institute at Central DuPage Hospital, Winfield, Illinois, 60190, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Oschner Clinic Foundation, New Orleans, Louisiana, 70121, United States|University of Maryland, Baltimore, Baltimore, Maryland, 21201, United States|Johns Hopkins University, Baltimore, Maryland, 21287, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Boston University Medical Center, Boston, Massachusetts, 02118, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|University of Michigan, Ann Arbor, Michigan, 48105, United States|Michigan State University, East Lansing, Michigan, 48824, United States|Henry Ford Health System, West Bloomfield, Michigan, 48322, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada, 89106, United States|Overlook Medical Center, Atlantic Neuroscience Institute, Summit, New Jersey, 07901, United States|Albany Medical College, Albany, New York, 12208, United States|SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States|Weill Cornell Medical Center, New York, New York, 10021, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Duke University, Durham, North Carolina, 27705, United States|University of Cincinnati/Cincinnati Children's Hospital, Cincinnati, Ohio, 45219, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University, Columbus, Ohio, 43221, United States|Oregon Health & Sciences University, Portland, Oregon, 97239, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19107, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Butler Hospital, Providence, Rhode Island, 02906, United States|Medical University of South Carolina, Charleston, South Carolina, 29403, United States|Wesley Neurology Clinic, PC, Cordova, Tennessee, 38018, United States|University of Tennessee Health Science Center, Memphis, Tennessee, 38163, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|UT Southwestern Medical Center, Dallas, Texas, 75390-9036, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|University of Texas Houston Medical School, Houston, Texas, 77030, United States|Baylor Scott & White Health, Temple, Texas, 76508, United States|The University of Vermont, Burlington, Vermont, 05405, United States|University of Virginia, Charlottesville, Virginia, 22908, United States|VCU Parkinson's & Movement Disorder Center (McGuire Veterans Hospital), Richmond, Virginia, 23230, United States|Sentara Neurology Specialists, Virginia Beach, Virginia, 23456, United States|Inland Northwest Research, Spokane, Washington, 99202, United States|Northwest Neurological PLLC, Spokane, Washington, 99202, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|University of Puerto Rico, San Juan, 935, Puerto Rico
- Other Id
- INO-PD-P3-2014|1U01NS090259-01A1
- Start Date
- 2016-06
- Primary Completion Date
- 2019-06
- Completion Date
- 2019-06
- First Posted
- 2015-12-30
- Results First Posted
- 2020-07-28
- Last Update Posted
- 2020-07-28
- Study Document
- Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/93/NCT02642393/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/93/NCT02642393/Prot_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02642393
- Title Cn
- Title En
- Study of Urate Elevation in Parkinson's Disease, Phase 3
- Bilingual Status
- semi_complete