A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease

A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease (NCT07170475) is a Phase 1 interventional studying Parkinson's Disease (PD), sponsored by Fujita Health University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Parkinson's Disease (PD), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to provide voluntary written willing to sign a consent form. 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 Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Febuxostat

Febuxostat tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.

DRUG

Inosine

Inosine tablets (per randomized assignment), administered orally twice daily (once in the morning and once in the evening) for 12 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fujita Health University

Toyoake, Aichi-ken, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07170475), the sponsor (Fujita Health University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07170475 clinical trial studying?

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 activit… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07170475?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07170475?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07170475. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07170475. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.