CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
Inosine +1 moredrug
Likely dose
Inosine 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02642393
NCT02642393Phase 3Completed
CompareCT.gov

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

Michael Alan Schwarzschild·interventional·Posted Dec 30, 2015·Updated Jul 28, 2020

In Brief

A Phase 3 clinical trial evaluating Inosine and Placebo for Parkinson's Disease. Completed, enrolled 298 participants across 62 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesPuerto Rico, United States
CollaboratorsThe Parkinson Study Group, Michael J. Fox Foundation for Parkinson's Research, University of Rochester, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartJun 1, 2016
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 10.5 years ago

Interventions

Inosinedrug

capsules containing 500 mg of inosine

Placebodrug

capsules containing \~500 mg of lactose and appearing indistinguishable from inosine capsules