A Phase Ib Trial of Combined Febuxostat and Inosine Therapy in Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in plasma hypoxanthine concentration from baseline to Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Requires almost total assistance in daily life and is unable to walk or stand unaided.
- •Currently taking azathioprine, mercaptopurine hydrate, vidarabine, didanosine, or rosuvastatin.
- •Used febuxostat, allopurinol, or topiroxostat within 3 months before study start.
- •Taking any supplement containing inosine.
- •Started any new Parkinson's disease medication or therapy within 3 months before enrollment.
- •Serum creatinine >1.5× upper limit of normal (ULN), or AST (GOT) or ALT (GPT) >2× ULN at screening.
- •History of surgical treatment for Parkinson's disease.
- •History of or comorbid hypersensitivity/allergy to any ingredient of the investigational drugs.
- •Participation in another clinical trial involving an unapproved drug within 30 days before consent, or currently enrolled in another interventional study.
- •Pregnant or breastfeeding, or unwilling/unable to use reliable contraception during the study period.
- •Positive test at screening for HIV, HBV, HTLV-1, or syphilis; **HCV antibody-positive with undetectable HCV RNA** is allowed.
- •Unable to take the investigational drugs orally without changing the dosage form.
- •Gastrointestinal disease or prior GI surgery that may affect drug absorption, as judged by the investigator.
- •Psychiatric disorder or symptoms that interfere with daily life and make study participation difficult.
- •Unable to complete assessments or questionnaires independently.
- •Any other condition that, in the investigator's judgment, would make participation unsafe or inappropriate.
研究组 & 干预措施
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.
干预措施: Febuxostat (Drug)
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.
干预措施: Inosine (Drug)
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.
干预措施: Febuxostat (Drug)
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.
干预措施: Inosine (Drug)
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.
干预措施: Febuxostat (Drug)
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.
干预措施: Inosine (Drug)
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.
干预措施: Febuxostat (Drug)
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.
干预措施: Inosine (Drug)
结局指标
主要结局
Change in plasma hypoxanthine concentration from baseline to Week 12
时间窗: 12 weeks
The difference in plasma hypoxanthine level (µmol/L) between pre-dose at Day 0 and Week 12 visit.
次要结局
- Change in Geriatric Depression Scale-15 (GDS-15) score from baseline to Week 12(12 weeks)
- Change in plasma hypoxanthine concentration from baseline to Week 4(4 weeks)
- Change in cerebrospinal fluid (CSF) hypoxanthine concentration from baseline to Week 12(12 weeks)
- Change in MDS-UPDRS Part III score from baseline to Week 12(12 weeks)
- Change in Mini-Mental State Examination (MMSE) score from baseline to Week 12(12 weeks)