Combined febuxostat and inosine treatment for people with early Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib, open-label trial enrolls 24 people with early Parkinson's disease to receive one of four oral dose regimens of febuxostat plus inosine taken twice daily for 12 weeks. Participants attend clinic visits at baseline and at weeks 4, 8, and 12 for blood tests (including hypoxanthine), neurological exams, and questionnaires, and keep a brief diary of side effects and daily changes. The main goal is to collect safety and tolerability data and to measure biochemical effects on purine metabolites. Results will inform whether the combination is safe enough to test in larger efficacy trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujita Health University
  Toyoake, Aichi-ken, Japan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.