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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.