Febuxostat for Parkinson's (NCT07170475)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- 4 clinic visits (baseline and weeks 4, 8, and 12) over 12 weeks.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.