Phase 1b Study of Twice-Daily Oral Febuxostat and Inosine for Early Parkinsons Disease

What this Trial Is About

Researchers are evaluating the safety of taking combined febuxostat and inosine orally twice daily in adults with early-stage Parkinsons disease who are on stable medication regimens. This Phase Ib trial involves 24 participants to assess safety over a 12-week period. The study aims to gather important safety data to guide future Parkinsons disease treatments. Participants are randomly assigned to one of four dose levels of febuxostat and inosine, taken twice a day morning and evening for 12 weeks. Each participant receives their assigned dose orally and follows the same dosing schedule throughout the study. During the trial, participants will visit the clinic at the start and at weeks 4, 8, and 12 for blood tests, physical exams, and questionnaires. They will also keep a simple diary to record any side effects or changes in daily activities. Researchers will primarily measure changes in plasma hypoxanthine levels and monitor Parkinsons disease symptoms and cognitive function using established scales. The total participation duration is approximately 12 weeks.

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