NCT07170475 A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
| NCT ID | NCT07170475 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fujita Health University |
| Condition | Parkinson's Disease (PD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-06-27 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Able to provide voluntary written informed consent. 2. Receiving stable Parkinson's disease medication (no changes in type or dose) for at least 3 months before enrollment. 3. Age 18 to 80 years at the time of consent. 4. 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: 1. Hoehn-Yahr stage (ON state) 1 to 3 2. MDS-UPDRS Part III (ON state) score 10 to 35 3. Mini-Mental State Examination (MMSE) score ≥ 24 Exclusion Criteria: 1. Requires almost total assistance in daily life and is unable to walk or stand unaided. 2. Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin. 3. Used febuxostat, allopurinol, or topiroxostat within 3 months before study start. 4. Taking any supplement containing inosine. 5. Started any new Parkinson's disease medication or therapy within 3 months before enrollment. 6. Serum creatinine \>1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) \>2× ULN at screening. 7. History of surgical treatment for Parkinson's disease. 8. History of or comorbid hypersensitivity/allergy to any ingredient of the investigational drugs. 9. Participation in another clinical trial involving an unapproved drug within 30 days before consent, or currently enrolled in another interventional study. 10. Pregnant or breastfeeding, or unwilling/unable to use reliable contraception during the study period. 11. Positive test at screening for HIV, HBV, HTLV-1, or syphilis; \*\*HCV antibody-positive with undetectable HCV RNA\*\* is allowed. 12. Unable to take the investigational drugs orally without changing the dosage form. 13. Gastrointestinal disease or prior GI surgery that may affect drug absorption, as judged by the investigator. 14. Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult. 15. Unable to complete assessments or questionnaires independently. 16. Any other condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
Frequently Asked Questions
Who can join the NCT07170475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Parkinson's Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07170475 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07170475 currently recruiting?
Yes, NCT07170475 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fujita Health University to inquire about joining.
Where is the NCT07170475 trial being conducted?
This trial is being conducted at Toyoake, Japan.
Who is sponsoring the NCT07170475 clinical trial?
NCT07170475 is sponsored by Fujita Health University. The trial plans to enroll 24 participants.
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