NCT00036296已完成1 期
Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease.
It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score >25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
- •Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
- •Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
- •Have been diagnosed with Parkinson's disease > 5 years at Screening
排除标准
- •Previous surgical therapies for PD
- •Isolated or predominantly diphasic dyskinesias
- •Moderate Dementia
- •On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.
研究组 & 干预措施
1
Experimental
75mg per day (in 3 doses) Talampanel for 22 days
干预措施: talampanel (Drug)
2
Placebo Comparator
3 doses a day for 22 days
干预措施: talampanel (Drug)
研究者
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