Evaluating Safety and Efficacy of Celecoxib in Patients With PD.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change in the Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Parkinson's disease (PD) is a chronic neurodegenerative disease clinically characterized by bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. These motor manifestations are attributed to the degeneration and selective loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc), leading to a dopamine (DA) deficiency in the striatum. Neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded as a potential inflammatory biomarker in PD
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both male and female will be included.
- •Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.
排除标准
- •Breast feeding
- •Patients with significant liver and kidney function abnormalities.
- •Alcohol and / or drug abusers.
- •Patients with known allergy to the study medications
- •Patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib).
- •Pregnant women and women with planned pregnancy.
- •Patients who are currently using other anti-inflammatory drugs.
研究组 & 干预措施
Control group
control group ( levo-dopa group, n =40 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.
干预措施: Levodopa Carbidopa (Drug)
Celecoxib group
will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus celecoxib 200 mg once daily.
干预措施: Levodopa Carbidopa (Drug)
Celecoxib group
will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus celecoxib 200 mg once daily.
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
change in the Unified Parkinson's Disease Rating Scale
时间窗: 6 months
\- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
次要结局
未报告次要终点