A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Recruiting · NCT07170475 · Interventional (participants receive a specific treatment) · Lead sponsor: Fujita Health University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
- Diagnosed with Parkinson's disease by a specialist according to MDS-PD diagnostic criteria, and at pre-enrollment screening, all of the following are met:
- Hoehn-Yahr stage (ON state) 1 to 3
- MDS-UPDRS Part III (ON state) score 10 to 35
- Mini-Mental State Examination (MMSE) score ≥ 24
Exclusion criteria
- 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.
- Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
- Serum creatinine \>1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) \>2× ULN at screening.
- History of surgical treatment for Parkinson's disease.
- History of or comorbid hypersensitivity/allergy to any ingredient of the investigational 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/unable to use reliable contraception during the study period.
- Positive test at screening for HIV, HBV, HTLV-1, or syphilis; \*\*HCV antibody-positive with undetectable HCV RNA\*\* is allowed.
- Unable to take the investigational 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, in the investigator's judgment, would make participation unsafe or inappropriate.
Where it is running
1 location listed.
- Fujita Health University - Toyoake, Aichi-ken, Japan