Tests febuxostat and inosine together in people with Parkinson's disease
Tests whether two oral drugs taken together are safe for people with early Parkinson's disease.
Plain-language title generated from the registry record
Registry title: A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Key facts
- Where
- Toyoake, JapanSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07170475, who can take part
Where in Japan
- Fujita Health UniversityToyoake, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujita Health University
- Trial code
- NCT07170475
- Record updated
- 12 September 2025
- Original description
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:Read full original descriptionShow less
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
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.
Inclusion: 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: Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin; Used febuxostat, allopurinol, or topiroxostat within 3 months before study start; Started any new Parkinson's disease medication or therapy within 3 months before enrollment; 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; 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; History of surgical treatment for Parkinson's disease; Positive test at screening for HIV, HBV, HTLV-1, or syphilis; **HCV antibody-positive with undetectable HCV RNA** is allowed; Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult; Any other condition that, in the investigator's judgment, would make participation unsafe or inappropriate; Serum creatinine >1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) >2× ULN at screening; Requires almost total assistance in daily life and is unable to walk or stand unaided; Taking any supplement containing inosine; Pregnant or breastfeeding, or unwilling/unable to use reliable contraception during the study period; Unable to complete assessments or questionnaires independently.