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

NCT02642393 ยท Status: COMPLETED ยท Phase: PHASE3 ยท Type: INTERVENTIONAL ยท Enrollment: 298

Last updated 2020-07-28

Study results available
ยท View outcomes & findings โ†’

Summary

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from โ‰ค5.7 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.

Conditions

Interventions

DRUG

Inosine

capsules containing 500 mg of inosine

DRUG

Placebo

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

Sponsors & Collaborators

  • The Parkinson Study Group

    collaborator NETWORK

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Michael Alan Schwarzschild

    lead OTHER

Principal Investigators

  • Michael A Schwarzschild, MD, PhD ยท Massachusetts General Hospital (PI of Clinical Coordinating Center), PSG (Chair, SURE-PD3 Steering Committee)

  • Alberto Ascherio, MD, DrPH ยท Harvard School of Public Health, PSG (Co-Chair, SURE-PD3 Steering Committee)

  • David Oakes, PhD ยท University of Rochester (PI of Data Coordinating Center), PSG (Study Statistician/Member, SURE-PD3 Steering Committee)

  • Eric A Macklin, PhD ยท Massachusetts General Hospital, PSG (Study Statistician/Member, SURE-PD3 Steering Committee)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642393 on ClinicalTrials.gov