NCT07170475RecruitingPhase 1
A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 7 Sept 2025
- Start date
- 27 Jun 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Fujita Health University
- Diseases
- Parkinson disease
- NCT number
- NCT07170475
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 27 Jun 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Serum creatinine \>1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) \>2× ULN at screening.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujita Health University Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.