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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized in parallel to one of four dose-combination groups and receive their assigned regimen twice daily for 12 weeks. Dosing is open-label, with febuxostat co-administered with inosine each morning and evening. Safety and pharmacodynamic blood measures are collected at baseline and at weeks 4, 8, and 12.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Febuxostat + Inosine （Dose Level 1)

Participants receive febuxostat and inosine (Dose Level 1) orally, twice daily (once in the morning and once in the evening) for 12 weeks.

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

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

Inosine

Intervention Type DRUG

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

Group 2 - Febuxostat + Inosine (Dose Level 2)

Participants receive febuxostat and inosine (Dose Level 2) orally, twice daily (once in the morning and once in the evening) for 12 weeks.

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

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

Inosine

Intervention Type DRUG

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

Group 3 - Febuxostat + Inosine (Dose Level 3)

Participants receive febuxostat and inosine (Dose Level 3) orally, twice daily (once in the morning and once in the evening) for 12 weeks.

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

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

Inosine

Intervention Type DRUG

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

Group 4 - Febuxostat + Inosine (Dose Level 4)

Participants receive febuxostat and inosine (Dose level 4) orally, twice daily (once in the morning and once in the evening) for 12 weeks.

Group Type EXPERIMENTAL

Febuxostat

Intervention Type DRUG

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

Inosine

Intervention Type DRUG

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

Interventions

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Febuxostat

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

Intervention Type DRUG

Inosine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No