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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Febuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
Inosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.
Fujita Health University
Toyoake, Aichi-ken, Japan
RECRUITINGChange 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.
Time frame: 12 weeks
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.
Time frame: 4 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12
The difference in MMSE score between Day 0 and Week 12.
Time frame: 12 weeks
Change in Geriatric Depression Scale-15 (GDS-15) score from baseline to Week 12
The difference in GDS-15 score between Day 0 and Week 12.
Time frame: 12 weeks
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