Actively Recruiting
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Led by Fujita Health University · Updated on 2025-09-12
24
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide voluntary written informed consent.
- Receiving stable Parkinson's disease medication with no changes in type or dose for at least 3 months before enrollment.
- Age 18 to 80 years at the time of consent.
- Diagnosed with Parkinson's disease by a specialist according to MDS-PD diagnostic criteria.
- Hoehn-Yahr stage (ON state) between 1 and 3.
- MDS-UPDRS Part III (ON state) score between 10 and 35.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
You will not qualify if you...
- Requires almost total assistance in daily life and is unable to walk or stand without help.
- 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.
- Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
- Serum creatinine higher than 1.5 times the upper limit of normal, or AST (GOT) or ALT (GPT) higher than 2 times the upper limit of normal at screening.
- History of surgical treatment for Parkinson's disease.
- History of or allergy to any ingredient of the study drugs.
- Participation in another clinical trial involving an unapproved drug within 30 days before consent or currently enrolled in another interventional study.
- Pregnant or breastfeeding, or unwilling or unable to use reliable contraception during the study.
- Positive screening test for HIV, HBV, HTLV-1, or syphilis; HCV antibody-positive with undetectable HCV RNA is allowed.
- Unable to take the study drugs orally without changing the dosage form.
- Gastrointestinal disease or prior GI surgery that may affect drug absorption as judged by the investigator.
- Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult.
- Unable to complete assessments or questionnaires independently.
- Any other condition that would make participation unsafe or inappropriate, as judged by the investigator.
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Trial Site Locations
Total: 1 location
1
Fujita Health University
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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