Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Time to need for dopaminergic therapy
研究概览
简要总结
The aim of this study is investigation of neuroprotective effect of zonisamide in early Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn&Yahr and modified Schwab&England activities of daily living scale will be determined and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. Primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. The mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-85 years
- •Symptoms and signs of idiopathic Parkinson disease for less than a month that do not lead to physical or psychosocial disability.
排除标准
- •Past history of treatment with antiparkinson drugs.
- •Past history of treatment with zonisamide
- •Hepatic insufficiency (ALT>2ULN)
- •Renal insufficiency (Cr>2mg/dl)
- •Self or family history of nephrolithiasis
- •Active psychosis
- •Suicidal attempt in last 3 years
- •Hypersensitivity to sulfonamides
- •Pregnancy and breastfeeding
研究组 & 干预措施
Zonisamide
The patients in this arm are treated with zonisamide 50mg/d
干预措施: Zonisamide (Drug)
Placebo
The patients in this arm are treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to need for dopaminergic therapy
时间窗: Baseline and month 6
次要结局
- change in UPDRS score(Baseline and month 12)
研究者
Nasim Tabrizi
Assistant professor of neurology
Mazandaran University of Medical Sciences