Test febuxostat and inosine neuroprotection
- Trial ID
- NCT07170475
- Official Title
- A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
- Goal
- Test febuxostat and inosine neuroprotection
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Fujita Health University
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Febuxostat, Inosine
Plain-Language Summary
The goal is to see if giving febuxostat together with inosine is safe and tolerable in people with Parkinson's while exploring whether changing purine and urate-related metabolism might offer neuroprotective benefits. The approach gives oral inosine, which raises purine metabolites including urate, alongside febuxostat, a xanthine oxidase inhibitor that blocks part of the uric acid production pathway so investigators can modulate those metabolites while monitoring safety; participants keep their usual Parkinson's medications because this is not a replacement for levodopa. The trial is recruiting adults 18 to 80 with specialist‑confirmed PD, Hoehn‑Yahr stage 1 to 3, MDS‑UPDRS Part III scores of 10 to 35, MMSE at least 24, and stable Parkinson's meds for at least 3 months, with exclusions for recent febuxostat or inosine use, certain other drugs or medical problems, advanced surgical PD treatment, and pregnancy.
Locations
- Fujita Health University, Toyoake, Aichi-ken, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Febuxostat. The goal is to see if giving febuxostat together with inosine is safe and tolerable in people with Parkinson's while exploring whether changing purine and urate-related metabolism might offer neuroprotective benefits. The approach gives oral inosine, which raises purine metabolites including urate, alongside febuxostat, a xanthine oxidase inhibitor that blocks part of the uric acid production pathway so investigators can modulate those metabolites while monitoring safety; participants keep their usual Parkinson's medications because this is not a replacement for levodopa. The trial is recruiting adults 18 to 80 with specialist‑confirmed PD, Hoehn‑Yahr stage 1 to 3, MDS‑UPDRS Part III scores of 10 to 35, MMSE at least 24, and stable Parkinson's meds for at least 3 months, with exclusions for recent febuxostat or inosine use, certain other drugs or medical problems, advanced surgical PD treatment, and pregnancy.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 9 months.