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NCT02642393 · ClinicalTrials.gov registry record · Phase 3
Study of Urate Elevation in Parkinson's Disease, Phase 3
A Phase 3 study of Parkinson's Disease, sponsored by Michael Alan Schwarzschild.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
- 20
- Study locations
NCT02642393: Completed Phase 3 study of Parkinson's Disease, sponsored by Michael Alan Schwarzschild.
NCT02642393 is a Phase 3 study of Parkinson's Disease that has completed, run by Michael Alan Schwarzschild. The registered enrollment target is 298 participants, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02642393, a Phase 3 study of Parkinson's Disease, has completed, sponsored by Michael Alan Schwarzschild.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inosine
Study Locations (20)
California
- University of California San Diego - La Jolla
- University of Southern California - Los Angeles
- University of California Davis - Sacramento
- University of California San Francisco - San Francisco
Arizona
- Barrow Neurological Institute - Phoenix
- Mayo Clinic Arizona - Scottsdale
- Banner Sun Health Research Institute - Sun City
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
- Neurosciences Institute at Central DuPage Hospital - Winfield
Colorado
- University of Colorado - Aurora
- Rocky Mountain Movement Disorder Center - Englewood
Georgia
- Emory University - Atlanta
- Augusta University - Augusta
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Hartford HealthCare Movement Disorders Center - Vernon
Florida
- University of South Florida - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-06 |
| Phase | Phase 3 |
What the finished NCT02642393 record still lists
NCT02642393 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02642393 names 20 study sites across 11 states, led by California, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT02642393 about?
NCT02642393 is a clinical study titled "Study of Urate Elevation in Parkinson's Disease, Phase 3". 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...
What is the current status of trial NCT02642393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2016-06. Estimated completion is 2019-06.
What conditions does trial NCT02642393 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT02642393?
The interventions under investigation include: Placebo (DRUG), Inosine (DRUG).
Who is sponsoring clinical trial NCT02642393?
This trial is sponsored by Michael Alan Schwarzschild, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02642393 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02642393's enrollment target sits among peer trials
298 28th of 158 higher than 131 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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