Clinical Study to Evaluate the Possible Efficacy and Safety of Fexofenadine in Patients With Parkinson's Disease Treated With Conventional Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Parkinson's disease (PD) is a chronic, progressive neurological disorder characterized by both motor and non-motor symptoms. PD is the second most common neurodegenerative disorder after Alzheimer's disease and the most common movement disorder. PD has age-related pathology; it is present in 1-2% of the population over 60 years of age. The disease is characterized by a triad of disordered voluntary motor activity in the form of bradykinesia (slowness of movement) or even akinesia (absence of movement),rigidity and postural instability, and a resting tremor of the hands and less commonly the feet.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years. Both male and female will be included. Patients with Parkinson's disease on dopamine replacement therapy. Modified Hoehn and Yahr stage, MHY 1-4
排除标准
- •Atypical parkinsonism or drug-induced parkinsonism Breast feeding Pregnant women and women with planned pregnancy. Patients with significant liver and kidney function abnormalities. History/presence of acute heart disease Alcohol and / or drug abusers. Patients with known allergy to the study medications Other medical conditions that can interfere with results or endanger the participant.
研究组 & 干预措施
control arm
will receive their standard dopamine replacement therapy for 6 months.
干预措施: Levodopa/carbidopa (Drug)
Fexofenadine group
will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months
干预措施: Levodopa/carbidopa (Drug)
Fexofenadine group
will receive Fexofenadine 180 mg once daily together with their standard dopamine replacement therapy for 6 months
干预措施: Fexofenadine (Drug)
结局指标
主要结局
The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale
时间窗: 6 months
The primary outcome is the change in quality of life in Parkinson's disease by Unified Parkinson's Disease Rating Scale
次要结局
未报告次要终点
研究者
Ihab Elsayed Hassan
Teaching Assistant
Tanta University