MedTrace Logo

Safety of Urate Elevation in Parkinson's Disease

NCT00833690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-06-05

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the safety and tolerability of inosine and its ability to raise urate levels in blood and cerebral spinal fluid in individuals with early Parkinson disease. This will determine whether it is appropriate to proceed with a larger study of inosine's ability to modify the rate of disability progression in PD.

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo

500 mg of inactive substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing adjusted algorithmically to parallel that in the inosine arms

DRUG

inosine

500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a mildly elevated serum urate range of 6.1 - 7.0 mg/dL

DRUG

inosine

500 mg of active substance per capsule; 1 to 6 capsules per day (in up to 3 divided doses) for 2 years; dosing titrated to a moderately elevated serum urate range of 7.1 - 8.0 mg/dL

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • The Parkinson Study Group

    lead NETWORK

Principal Investigators

  • Michael A Schwarzschild, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00833690 on ClinicalTrials.gov