RecruitingPhase 1NCT07170475

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


Sponsor

Fujita Health University

Enrollment

24 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — febuxostat (a gout medication) and inosine (a natural compound) — to see if they can slow the progression of Parkinson's disease by raising uric acid levels in the blood, which may protect brain cells. **You may be eligible if...** - You are between 18 and 80 years old with a diagnosed Parkinson's disease - Your Parkinson's is mild to moderate (Hoehn-Yahr stage 1–3) - You have been on stable Parkinson's medications for at least 3 months - Your memory and thinking are intact (MMSE score 24 or higher) **You may NOT be eligible if...** - You need almost total help with daily activities or cannot walk or stand - You take certain medications including azathioprine, mercaptopurine, or rosuvastatin - You used gout medications (febuxostat, allopurinol, topiroxostat) in the last 3 months - You already take inosine supplements - You have had surgery for Parkinson's disease - Your kidney or liver tests are significantly abnormal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFebuxostat

Febuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.

DRUGInosine

Inosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.


Locations(1)

Fujita Health University

Toyoake, Aichi-ken, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07170475


Related Trials