This study will test the safety of twice-daily oral dosing of combined febuxostat and inosine in 24 patients with Parkinson's disease. Participants will receive one of the four regimens, taken twice daily for 12 weeks:
Who can join: Adults with early-stage Parkinson's disease on stable medication regimens.
What participants do:
* Take their assigned dose twice daily (morning and evening) for 12 weeks. * Visit the clinic at baseline and weeks 4, 8, and 12 for blood tests (including hypoxanthine), exams, and questionnaires. * Keep a simple diary of any side effects or changes in daily activities.
Risks and benefits: Possible side effects include mild gastrointestinal upset, headache, or elevated uric acid levels. While direct benefit is not guaranteed, this safety data will inform future Parkinson's disease treatments.
Learn more: Contact \[site-specific contact info\] for details on eligibility and enrollment.
Able to provide voluntary written informed consent.
Receiving stable Parkinson's disease medication (no changes in type or dose) for at least 3 months before enrollment.
Age 18 to 80 years at the time of consent.
Hoehn-Yahr stage (ON state) 1 to 3
Requires almost total assistance in daily life and is unable to walk or stand unaided.
Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin.
Used febuxostat, allopurinol, or topiroxostat within 3 months before study start.
Taking any supplement containing inosine.
Parallel
Febuxostat
DrugFebuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
Inosine
DrugInosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
Change in plasma hypoxanthine concentration from baseline to Week 12
The difference in plasma hypoxanthine level (µmol/L) between pre-dose at Day 0 and Week 12 visit.
Change in plasma hypoxanthine concentration from baseline to Week 4
The difference in plasma hypoxanthine level between pre-dose at Day 0 and Week 4 visit.
Change in cerebrospinal fluid (CSF) hypoxanthine concentration from baseline to Week 12
The difference in CSF hypoxanthine level between the pre-dose at Day 0 and the Week 12 visit.
Change in MDS-UPDRS Part III score from baseline to Week 12
The difference in Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor examination (ON state) score between Day 0 and Week 12.
Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12
The difference in MMSE score between Day 0 and Week 12.
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