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Official Study Title: A Randomized, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Placebo-Controlled, Dose-Ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease
Sponsor: Michael Schwarzschild, MD, PhD; This study is being funded by a grant from the Michael J. Fox Foundation for Parkinson’s Research.
Clinicaltrials.gov ID: NCT00833690
Study ID: INO-PD-P2-2008

Summary

The purpose of this study is to determine the safety and tolerability of inosine (a nutritional supplement) and its ability to raise urate (also known as  uric acid) levels in blood and cerebral spinal fluid in individuals with early Parkinson’s disease (PD). 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.

Ninety untreated participants diagnosed with idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD will be enrolled at 17 sites across the U.S. and randomized to one of three treatment groups: 1) those who will receive placebo,  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. 2) those who will receive inosine dosed to produce a mild elevation in urate levels, and 3) those who will receive inosine dosed to produce a moderate elevation in urate levels.

Tolerability, validity (urate elevation), dosage and symptomatic efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. will be assessed after half the participants have completed 12 weeks of treatment and again after all the participants have completed 12 weeks. Contingent on adequate tolerability and validity as assessed in the short-term analyses, the study will continue for two years total duration with two groups (placebo and a single inosine dosing group) or the original three groups to assess long-term tolerability and safety.  The main known risks are urolithiasis (a condition marked by stones in the urinary tract), gouty arthritis and the theoretical risk of cardiovascular disease.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Movement and Non-movement

General PD symptoms

Time Commitment

• More than six months
• 2 screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. visits, a baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visit, 12 visits on study drug over 24 months, and a final visit 1 month later (for a total of 16 visits over about 26 months)

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 3

Inclusion Criteria

• Idiopathic PD with at least two of the cardinal signs of PD (resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. bradykinesia,  BradykinesiaSlowness of movement. rigidity)  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body.
• Currently not taking or needing any treatment for PD other than an MAO-B inhibitor
• Age 30 or older at the time of PD diagnosis
• Diagnosis of PD made within past 3 years
• Specified urate levels at screening visits
  

Exclusion Criteria

• History of kidney stones, gout, stroke, or heart attack
• History of renal disease or certain cardiovascular problems within the past year
• Acidic urine, uric acid, or urate crystalluria at screening as determined by clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. exam
• Use of certain medications including co-enzyme Q, creatine, higher than average amount of vitamin E daily, and higher than average amount of vitamin C daily. (A standard daily multivitamin is permitted.)
• Use of anti-PD and other medications targeting central nervous system dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. transmission
• Known unstable medical or psychiatric condition that may compromise participation in the study
• Women who are pregnant or lactating

Enrollment

Expected Enrollment: 90 (US)
Date Enrollment Began: Jun 2009
Date Enrollment Ends: May 2011
Last Updated Date: Aug 23 2010
Trial Post Date: Jun 23 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00833690?term=NCT00833690&rank=1

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