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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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

Locations
Other Locations
Japan
Fujita Health University
RECRUITING
Toyoake
Time Frame
Start Date: 2025-06-27
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 24
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Sponsors
Leads: Fujita Health University

This content was sourced from clinicaltrials.gov