NCT04173832Unknown不适用
A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Unified Dyskinesia Rating Scale (UDysRS)
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.
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
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients between the ages of 30-85;
- •Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
- •The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
- •The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
- •Levodopa is administered at least three times a day.
排除标准
- •PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
- •pregnant and lactating women;
- •Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
- •Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- •Psychiatric symptoms associated with anti-Parkinson's disease drugs
- •accompanied by a history of mental illness;
- •impaired liver and kidney function;
- •accompanied by severe other systemic diseases;
- •Amantadine treatment has been received within the first 30 days of enrollment;
- •History of medication with apomorphine or dopamine receptor antagonists;
- •Previously taking amantadine, unable to tolerate;
- •Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions;
- •Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
- •has received PD-related brain surgery;
- •Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days;
- •Patients who are unable to follow up with follow-up.
研究组 & 干预措施
Tianqi Pingchan Granule Combined With Amantadine
Experimental
干预措施: Tianqi Pingchan Granule Combined With Amantadine (Drug)
placebo Combined With Amantadine
Placebo Comparator
干预措施: Placebo Combined With Amantadine (Drug)
结局指标
主要结局
Unified Dyskinesia Rating Scale (UDysRS)
时间窗: up to 12 weeks
The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
次要结局
- Patient diaries(up to 12 weeks)
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(up to 12 weeks)
- Clinical Global Impression(up to 12 weeks)
研究者
研究点 (1)
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