Clinical Trial

A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease

Study acronym: iFRESH-PD
Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated September 12, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07170475
Lead Sponsor Fujita Health University
Conditions Parkinson's Disease (PD)
Enrollment 24 participants
Start Date 2025-06-27
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-12