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Could a gout drug and a supplement help Parkinson's? early trial begins

NCT ID NCT07170475

Knowledge-focused Sponsor: Fujita Health University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial will test the safety of combining two drugs—febuxostat (used for gout) and inosine (a natural substance)—in 24 adults with early-stage Parkinson's disease. Participants will take one of four dose combinations twice daily for 12 weeks, with regular blood tests and checkups. The goal is to see if the combination is safe and to measure changes in a blood marker called hypoxanthine, which may help guide future Parkinson's treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
febuxostat and inosine
What this could lead to
If successful, this safety data could point toward a new treatment approach for Parkinson's disease.
What could go wrong
This is a very early phase 1 trial with only 24 participants, so it may not lead to a proven treatment. Side effects like gastrointestinal upset or elevated uric acid are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease (PD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fujita Health University

    RECRUITING

    Toyoake, Aichi-ken, 470-1192, Japan

More trials for these conditions

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