---
title: Test febuxostat and inosine neuroprotection
nct_id: NCT07170475
phase: PHASE1
status: RECRUITING
sponsor: Fujita Health University
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07170475"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07170475"
last_fetched: "2026-05-10T14:07:07.616Z"
source: "Parkinson's Pathways (curated)"
---
# Test febuxostat and inosine neuroprotection

**Goal (in five words):** Test febuxostat and inosine neuroprotection

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

**Trial ID:** [NCT07170475](https://clinicaltrials.gov/study/NCT07170475)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Fujita Health University
- **Target Enrollment:** 24 participants
- **Start Date:** 2025-06-27
- **Completion Date:** 2026-03-31
- **Conditions:** Parkinson's Disease (PD)
- **Interventions:** Febuxostat, Inosine
- **Intervention Types:** DRUG

## Summary For Families

The goal is to see if giving febuxostat together with inosine is safe and tolerable in people with Parkinson's while exploring whether changing purine and urate-related metabolism might offer neuroprotective benefits. The approach gives oral inosine, which raises purine metabolites including urate, alongside febuxostat, a xanthine oxidase inhibitor that blocks part of the uric acid production pathway so investigators can modulate those metabolites while monitoring safety; participants keep their usual Parkinson's medications because this is not a replacement for levodopa. The trial is recruiting adults 18 to 80 with specialist‑confirmed PD, Hoehn‑Yahr stage 1 to 3, MDS‑UPDRS Part III scores of 10 to 35, MMSE at least 24, and stable Parkinson's meds for at least 3 months, with exclusions for recent febuxostat or inosine use, certain other drugs or medical problems, advanced surgical PD treatment, and pregnancy.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Fujita Health University, Toyoake, Aichi-ken, Japan _(35.0380, 136.9993)_
  - Keiko Uesugi, Registered Nurse — (CONTACT) — 81-562-93-9362 — kuesugi@fujita-hu.ac.jp
  - Hirohisa Watanabe, MD. PhD. — (PRINCIPAL_INVESTIGATOR)

---

*Canonical: https://parkinsonspathways.com/trial/NCT07170475*  
*HTML version: https://parkinsonspathways.com/trial/NCT07170475*  
*Source data: https://clinicaltrials.gov/study/NCT07170475*