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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFujita Health University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Hoehn-Yahr stage (ON state) 1 to 3

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Febuxostat
  • Inosine

Treatment groups

24 Participants
are divided into 4 treatment groups

Sponsors and collaborators