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Recruiting

NCT Number: NCT07170475

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

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.

Recruiting

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

Location status: Recruiting

Location contact

Hirohisa Watanabe, MD. PhD.

PRINCIPAL_INVESTIGATOR

Keiko Uesugi, Registered Nurse

CONTACT

[email protected]

81-562-93-9362

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide voluntary written informed consent.
  • Receiving stable Parkinson's disease medication (no changes in type or dose) for at least 3 months before enrollment.
  • Age 18 to 80 years at the time of consent.
  • 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:
  • Hoehn-Yahr stage (ON state) 1 to 3
  • MDS-UPDRS Part III (ON state) score 10 to 35
  • Mini-Mental State Examination (MMSE) score ≥ 24

Exclusion criteria

  • Requires almost total assistance in daily life and is unable to walk or stand unaided.
  • Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin.
  • Used febuxostat, allopurinol, or topiroxostat within 3 months before study start.
  • Taking any supplement containing inosine.
  • Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
  • Serum creatinine >1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) >2× ULN at screening.
  • History of surgical treatment for Parkinson's disease.
  • History of or comorbid hypersensitivity/allergy to any ingredient of the investigational drugs.
  • Participation in another clinical trial involving an unapproved drug within 30 days before consent, or currently enrolled in another interventional study.
  • Pregnant or breastfeeding, or unwilling/unable to use reliable contraception during the study period.
  • Positive test at screening for HIV, HBV, HTLV-1, or syphilis; **HCV antibody-positive with undetectable HCV RNA** is allowed.
  • Unable to take the investigational drugs orally without changing the dosage form.
  • Gastrointestinal disease or prior GI surgery that may affect drug absorption, as judged by the investigator.
  • Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult.
  • Unable to complete assessments or questionnaires independently.
  • Any other condition that, in the investigator's judgment, would make participation unsafe or inappropriate.

Treatment and study plan

Febuxostat

Drug

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

inosine

Drug

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

Primary outcomes

  1. Change in plasma hypoxanthine concentration from baseline to Week 12

    Time frame: 12 weeks

    The difference in plasma hypoxanthine level (µmol/L) between pre-dose at Day 0 and Week 12 visit.

Secondary outcomes

  1. Change in plasma hypoxanthine concentration from baseline to Week 4

    Time frame: 4 weeks

    The difference in plasma hypoxanthine level between pre-dose at Day 0 and Week 4 visit.

  2. Change in cerebrospinal fluid (CSF) hypoxanthine concentration from baseline to Week 12

    Time frame: 12 weeks

    The difference in CSF hypoxanthine level between the pre-dose at Day 0 and the Week 12 visit.

  3. Change in MDS-UPDRS Part III score from baseline to Week 12

    Time frame: 12 weeks

    The difference in Movement Disorder Society-Unified Parkinson's Disease Rating Scale motor examination (ON state) score between Day 0 and Week 12.

  4. Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12

    Time frame: 12 weeks

    The difference in MMSE score between Day 0 and Week 12.

  5. Change in Geriatric Depression Scale-15 (GDS-15) score from baseline to Week 12

    Time frame: 12 weeks

    The difference in GDS-15 score between Day 0 and Week 12.

Sponsors and collaborators

Lead sponsor

Fujita Health University

Other

Registry information

Acronym: iFRESH-PD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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