A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor Symptoms
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 主要终点
- Evaluation of the efficacy on motor symptoms and non-motor symptoms
研究概览
简要总结
On May 30,2018 ,Investigators intend to conduct a multicenter, randomized, double-blind, placebo-controlled study of idebenone in the treatment of early-stage Parkinson's disease with motor and non-motor symptoms which is to observe the therapeutic effect of idebenone on motor symptoms and non-motor symptoms in patients with early Parkinson's disease。
详细描述
This clinical trail was a multicenter, parallel, randomized, double-blind, placebo-controlled study led by Professor Liu Chunfeng from the Second Affiliated Hospital of Suzhou University which consisted of 15 sub-centers with a total of 180 subjects.
This clinical study is divided into two phases:
The first stage: double-blind period, 24 weeks. Three queues containing idebenone 180 mg/d,360 mg/d and placebo.
The second stage: open label extension period, 24 weeks. All enrolled participants continued to take idebenone 180 mg/d to study the long-term effects of idebenone.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Male or female, age > 30 years old, ≤ 80 years old;
- •(2) Conforms to the "Diagnostic Criteria for Parkinson's Disease" developed by the 2015 International Association of Sports Disabilities (MDS);
- •(3) Patients with early Parkinson's disease, duration <3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points;
- •(4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment;
- •(5) The subjects need to sign the Informed Consent Form（ICF）
排除标准
- •(1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)
- •(2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)
- •(3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);
- •(4)Patients who have taken coenzyme Q10 or idebenone within three months;
- •(5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;
- •(6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);
- •(7)Patients who cannot cooperate with the neuropsychological test;
- •(8) Patients with poor compliance, not following the prescribed treatment regimen.
研究组 & 干预措施
The control group 1
60 cases, idebenone 180mg/d, 3 times / day, oral
干预措施: Idebenone/placebo (Drug)
The control group 2
60 cases, idebenone 360mg/d, 3 times / day, oral
干预措施: Idebenone/placebo (Drug)
The placebo group
60 cases, placebo, 3 times / day, oral
干预措施: Idebenone/placebo (Drug)
结局指标
主要结局
Evaluation of the efficacy on motor symptoms and non-motor symptoms
时间窗: 48weeks
UPDRS-III Hoehn-Yahr classification Olfactory function test Anxiety and depression: Anxiety and Depression Scale (HAD)
次要结局
未报告次要终点