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Completed · registry status

Study of Urate Elevation in Parkinson's Disease, Phase 3

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT02642393

The registry title is shown while an English plain-language introduction is prepared. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Results reported

Start (reported actual date)
2016-06
Main measurements finished (reported actual date)
2019-06
Study finished (reported actual date)
2019-06

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry ↗

Changes we have recorded
  • 2026-10-11 — completed

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Improving Prediction of Falls and Cognitive Impairment in Parkinson Disease: Protocol for a Decentralized Observational Study
This paper mentions the study ID; the relationship needs review · 2025

Improving Prediction of Falls and Cognitive Impairment in Parkinson Disease: Protocol for a Decentralized Observational Study (Preprint)
This paper mentions the study ID; the relationship needs review · 2025

Di Luca DG, Macklin EA, Hodgeman K, Lopez G, Pothier L, Callahan KF, Lowell J, Chan J, Videnovic A, Lungu C, Lang AE, Litvan I, Schwarzschild MA, Simuni T. Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials. Neurol Clin Pract. 2023 Feb;13(1):e200113. doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18. ↗
Registry derived research reference

Parkinson Study Group SURE-PD3 Investigators; Schwarzschild MA, Ascherio A, Casaceli C, Curhan GC, Fitzgerald R, Kamp C, Lungu C, Macklin EA, Marek K, Mozaffarian D, Oakes D, Rudolph A, Shoulson I, Videnovic A, Scott B, Gauger L, Aldred J, Bixby M, Ciccarello J, Gunzler SA, Henchcliffe C, Brodsky M, Keith K, Hauser RA, Goetz C, LeDoux MS, Hinson V, Kumar R, Espay AJ, Jimenez-Shahed J, Hunter C, Christine C, Daley A, Leehey M, de Marcaida JA, Friedman JH, Hung A, Bwala G, Litvan I, Simon DK, Simuni T, Poon C, Schiess MC, Chou K, Park A, Bhatti D, Peterson C, Criswell SR, Rosenthal L, Durphy J, Shill HA, Mehta SH, Ahmed A, Deik AF, Fang JY, Stover N, Zhang L, Dewey RB Jr, Gerald A, Boyd JT, Houston E, Suski V, Mosovsky S, Cloud L, Shah BB, Saint-Hilaire M, James R, Zauber SE, Reich S, Shprecher D, Pahwa R, Langhammer A, LaFaver K, LeWitt PA, Kaminski P, Goudreau J, Russell D, Houghton DJ, Laroche A, Thomas K, McGraw M, Mari Z, Serrano C, Blindauer K, Rabin M, Kurlan R, Morgan JC, Soileau M, Ainslie M, Bodis-Wollner I, Schneider RB, Waters C, Ratel AS, Beck CA, Bolger P, Callahan KF, Crotty GF, Klements D, Kostrzebski M, McMahon GM, Pothier L, Waikar SS, Lang A, Mestre T. Effect of Urate-Elevating Inosine on Early Parkinson Disease Progression: The SURE-PD3 Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):926-939. doi: 10.1001/jama.2021.10207. ↗
Registry derived research reference

Mestre TA, Macklin EA, Ascherio A, Ferreira JJ, Lang AE, Schwarzschild MA; Parkinson Study Group SURE-PD3 Investigators. Expectations of Benefit in a Trial of a Candidate Disease-Modifying Treatment for Parkinson Disease. Mov Disord. 2021 Aug;36(8):1964-1967. doi: 10.1002/mds.28630. Epub 2021 May 4. ↗
Registry derived research reference

Participation rules recorded for this study

Age 30 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

INCLUSION CRITERIA: Study subjects meeting all of the following criteria will be allowed to enroll in the study: 1. Willingness and ability to give written informed consent and to comply with trial procedures. 2. Fulfillment of diagnostic criteria for idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity) present at 2nd screening and baseline evaluations, as assessed by the Site Investigator. 3. Absence of current or imminent (within 90 days of enrollment) PD disability requiring dopaminergic therapy, as assessed by the Site Investigator. 4. Modified Hoehn and Yahr Scale Stage 1 to 2.5 inclusive. 5. Age 30 or older at the time of PD diagnosis. 6. Diagnosis of PD made within 3 years prior to 1st Screening Visit. 7. Non-fasting serum urate ≤ 5.7 mg/dL at 1st Screening Visit (SC1). 8. If the subject is female, then: 1. Being surgically sterile (hysterectomy or tubal ligation), or 2. Being postmenopausal (last menstruation was two years or more prior to 2nd Screening Visit), or 3. For those of childbearing potential * Using a reliable form of contraception for 60 days or more prior to Baseline Visit and agreeing to continue such use for 30 days post last dose of study drug. Reliable forms of contraception include: abstinence; implanted, injected or oral contraceptives (birth control pills), intrauterine device in place for at least 3 months prior to Baseline Visit, vaginal ring with spermicide, barrier with spermicide such as male or female condom, diaphragm or cervical cap, transdermal patch; male partner with vasectomy. * And having a negative pregnancy test at the 2nd Screening Visit. \[Note that a urine pregnancy test will be performed at screening on all women who are not at least two years postmenopausal or surgically sterile.\] EXCLUSION CRITERIA: Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study: 1. Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease. 2. Dopamine transporter (DAT) brain scan without evidence of dopamine deficit. 3. History of gout. 4. History of uric acid or urate urolithiasis, or recurrent urolithiasis all of unknown type. 5. A screening test positive for uric acid crystalluria, urine pH ≤ 5.0, or an estimated glomerular filtration rate \< 60 ml/min/1.73 m2. 6. History of myocardial infarction or stroke. 7. Symptomatic congestive heart failure with a documented ejection fraction below 45%. 8. History of severe chronic obstructive pulmonary disease. 9. Mini Mental State Exam score \< 25; i.e., a score of 0 to 24. 10. Use of any anti-parkinsonian medication (including levodopa, dopamine agonists, amantadine, entacapone and the anticholinergic agents trihexyphenidyl and benztropine) other than monoamine oxidase-B inhibitors within 60 days of Baseline, or in excess of 90 days. 11. Change in the dosage of (or initiation of) a monoamine oxidase-B (MAO-B) inhibitor within 90 days prior to Baseline, i.e., entry on a MAO-B inhibitor requires a stable dosage for the 90 days prior to Baseline. 12. Use of the following within 30 days prior to the Baseline Visit: inosine, allopurinol, febuxostat, probenecid, more than 50 IU of vitamin E daily, or more than 300 mg of vitamin C daily (though a daily standard multivitamin such as Bayer One-A-Day® or Centrum® is permissible), reserpine, methylphenidate, amphetamines, cinnarizine, monoamine oxidase-A inhibitors, tetrabenazine, neuroleptics or other dopamine blocking drugs. 13. Use of the following within 90 days prior to the DAT neuroimaging screening evaluation: modafinil, armodafinil, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, or amphetamine derivative. 14. Unstable dosing of a thiazide -- such as hydrochlorothiazide (e.g., Esidrex), chlorothiazide (e.g., Diuril), chlorthalidone (e.g., Hygroton), indapamide (e.g., Lozol), metolazone (e.g., Zaroxolyn), which are permissible as long as the subject is on a stable dose from 1 week prior to the 1st Screening Visit through the Baseline Visit. 15. Known unstable medical or psychiatric condition that may compromise participation in the study. (Note that difficulty swallowing large capsules might preclude participation due to the size of the study drug capsules.) 16. Clinically serious abnormality in the screening visit laboratory studies or ECG, as determined by the Site Investigator. 17. Participation in another investigational treatment study within 30 days prior to the Baseline Visit. 18. Known hypersensitivity or intolerability to inosine. 19. Known hypersensitivity to DaTscan (either the active substance of ioflupane I-123 or to any of the excipients).
Full study name & original research details

Official study title

A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease

Short title used by the registry

Study of Urate Elevation in Parkinson's Disease, Phase 3

Original description

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD. Clinical decline will be assessed as change in the primary outcome variable of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a composite scale comprising patient- and clinician-reported outcomes.

Further description from the registry

Capsules containing 500 mg of inosine (active drug) or \~500 mg of lactose (placebo) will be taken orally up to two capsules three times per day (i.e., up to 3 g/day) for 24 months. In the inosine-treated group the number of capsules taken per day will be titrated to serum urate levels - measured at trough at study visits no more than three months apart - in order to achieve concentrations of 7.1-8.0 mg/dL. Initial dosing will be tailored to individualized factors including gender and pretreatment serum urate, and then advanced gradually toward the projected target dose. Adjustments in dosing of placebo capsules in the control arm will be algorithm-based to match dosing of inosine capsules in the active drug arm. Following study drug discontinuation all subjects will be followed during a 3-month wash-out period by telephone calls and a final study visit. All study visits after screening will include measurement of the primary outcome variable (MDS-UPDRS) and most will include secondary outcome variables: adverse events, dose adjustments, disability warranting initiation of dopaminergic therapy, Quality of Life in Neurological Disorders (Neuro-QOL), 39-item Parkinson's Disease Questionnaire (PDQ-39), Schwab \& England Activities of Daily Living (S\&E ADL) scale, Montreal Cognitive Assessment (MoCA), and orthostatic vital signs.

Conditions reported: Parkinson's Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Inosine; Placebo
Phases
PHASE3
Sponsor
Michael Alan Schwarzschild
Start date reported by registry
2016-06 (actual)

Registry updated: 2020-07-28 · Status last verified by the registry submitter: 2020-07

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Status not reported

Barrow Neurological Institute

Phoenix, Arizona, United States

Status not reported

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Status not reported

Banner Sun Health Research Institute

Sun City, Arizona, United States

Status not reported

University of California San Diego

La Jolla, California, United States

Status not reported

University of Southern California

Los Angeles, California, United States

Status not reported

University of California Davis

Sacramento, California, United States

Status not reported

University of California San Francisco

San Francisco, California, United States

Status not reported

University of Colorado

Aurora, Colorado, United States

Status not reported

Rocky Mountain Movement Disorder Center

Englewood, Colorado, United States

Status not reported

Hartford HealthCare Movement Disorders Center

Vernon, Connecticut, United States

Status not reported

University of South Florida

Tampa, Florida, United States

Status not reported

Emory University

Atlanta, Georgia, United States

Status not reported

Augusta University

Augusta, Georgia, United States

Status not reported

Northwestern University

Chicago, Illinois, United States

Status not reported

Rush University Medical Center

Chicago, Illinois, United States

Status not reported

Neurosciences Institute at Central DuPage Hospital

Winfield, Illinois, United States

Status not reported

Indiana University

Indianapolis, Indiana, United States

Status not reported

University of Kansas Medical Center

Kansas City, Kansas, United States

Status not reported

University of Louisville

Louisville, Kentucky, United States

Status not reported

Oschner Clinic Foundation

New Orleans, Louisiana, United States

Status not reported

University of Maryland, Baltimore

Baltimore, Maryland, United States

Status not reported

Johns Hopkins University

Baltimore, Maryland, United States

Status not reported

Massachusetts General Hospital

Boston, Massachusetts, United States

Status not reported

Boston University Medical Center

Boston, Massachusetts, United States

Status not reported

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Status not reported

University of Michigan

Ann Arbor, Michigan, United States

Status not reported

Michigan State University

East Lansing, Michigan, United States

Status not reported

Henry Ford Health System

West Bloomfield, Michigan, United States

Status not reported

Washington University School of Medicine

St Louis, Missouri, United States

Status not reported

University of Nebraska Medical Center

Omaha, Nebraska, United States

Status not reported

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Status not reported

Overlook Medical Center, Atlantic Neuroscience Institute

Summit, New Jersey, United States

Status not reported

Albany Medical College

Albany, New York, United States

Status not reported

SUNY Downstate Medical Center

Brooklyn, New York, United States

Status not reported

Weill Cornell Medical Center

New York, New York, United States

Status not reported

SUNY Upstate Medical University

Syracuse, New York, United States

Status not reported

Duke University

Durham, North Carolina, United States

Status not reported

University of Cincinnati/Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Status not reported

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Status not reported

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Status not reported

Ohio State University

Columbus, Ohio, United States

Status not reported

Oregon Health & Sciences University

Portland, Oregon, United States

Status not reported

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Status not reported

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Status not reported

Butler Hospital

Providence, Rhode Island, United States

Status not reported

Medical University of South Carolina

Charleston, South Carolina, United States

Status not reported

Wesley Neurology Clinic, PC

Cordova, Tennessee, United States

Status not reported

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Status not reported

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Status not reported

UT Southwestern Medical Center

Dallas, Texas, United States

Status not reported

Baylor College of Medicine

Houston, Texas, United States

Status not reported

University of Texas Houston Medical School

Houston, Texas, United States

Status not reported

Baylor Scott & White Health

Temple, Texas, United States

Status not reported

The University of Vermont

Burlington, Vermont, United States

Status not reported

University of Virginia

Charlottesville, Virginia, United States

Status not reported

VCU Parkinson's & Movement Disorder Center (McGuire Veterans Hospital)

Richmond, Virginia, United States

Status not reported

Sentara Neurology Specialists

Virginia Beach, Virginia, United States

Status not reported

Inland Northwest Research

Spokane, Washington, United States

Status not reported

Northwest Neurological PLLC

Spokane, Washington, United States

Status not reported

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Status not reported

University of Puerto Rico

San Juan, Massachusetts, Puerto Rico

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.