Phase 2
Completed N=75
Safety of Urate Elevation in Parkinson's Disease
Source: ClinicalTrials.gov NCT00833690 ↗Enrolled (actual)
75
Serious AEs
20.0%
Results posted
Jun 2014
Primary outcomePrimary: Tolerability — 96; 96; 100 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability |
86; 92; 96 | — |
| PRIMARY Safety |
11; 2; 4 | — |
| SECONDARY CSF Urate (All Patients) |
427; 544; 594 | — |
| SECONDARY CSF Urate (Females) |
285; 517; 575 | — |
| SECONDARY CSF Urate (Males) |
546; 586; 619 | — |
| SECONDARY CSF Urate as a Proportion of Baseline Serum Urate (All Patients) |
9.6; 13.1; 13.4 | — |
| SECONDARY CSF Urate as a Proportion of Baseline Serum Urate (Females) |
6.7; 13.5; 13.3 | — |
| SECONDARY CSF Urate as a Proportion of Baseline Serum Urate (Males) |
12.0; 12.4; 13.4 | — |
| SECONDARY Serum Urate |
4.74; 4.69; 4.38 | — |
| SECONDARY Change in Serum Urate |
0.12; -1.8; -3.2 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic PD with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity)
- Currently not taking or needing any treatment for PD other than an monoamine oxidase-B (MAO-B) inhibitor
- Age 30 or older at the time of PD diagnosis
- Diagnosis of PD made within past 3 years
- Serum urate ≤ 5.8 mg/dL at initial screening
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 (pH ≤ 5.0), uric acid, or urate crystalluria at screening
- Use of certain medications including co-enzyme Q, creatine, more than 50 IU of vitamin E daily, and more than 300 mg of vitamin C daily. (A standard daily multivitamin is permitted.)
- Use of anti-PD and other medications targeting central nervous system dopamine transmission
- Known unstable medical or psychiatric condition that may compromise participation in the study
- Women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00833690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.