Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Dyskinesia - UDysRS
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
详细描述
Plan: We will perform a randomized, placebo-controlled, double-blind, two-period cross-over study to evaluate the safety, tolerability, and efficacy of a novel treatment combination for LID in PD.
Methods: Eligible subjects who consent to participate in this study will be randomized to one of two sequences of treatment interventions during the baseline visit. Each treatment sequence includes placebo and buspirone interventions. After randomization, each participant will titrate up on study drug for two weeks ending in 30 mg/day. At the end of each two week study drug period, the participant will then have a study visit at the VA Portland Health Care System that includes safety monitoring, adverse event monitoring, drug compliance, and several measurements of LID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease diagnosis
- •Currently taking a levodopa containing medication for Parkinson's disease
- •Mild to Severe dyskinesia
- •Currently taking between 200-500 mg of amantadine daily for treatment of levodopa-induced dyskinesia with insufficient suppression levodopa-induced dyskinesia.
- •Stable medication regimen for at least 4 weeks prior to study.
排除标准
- •Currently receiving any other treatment for levodopa-induced dyskinesia, including but not exclusive to deep brain stimulation.
- •Not able to follow verbal commands
- •Not able to stand unsupported for at least 60 seconds
- •Not able to answer a patient questionnaire about their symptoms of Parkinson's disease and dyskinesia.
- •Have proprioceptive deficits.
- •Have a history of hepatic impairment
- •Currently have severe renal impairment
- •Currently have any other medical or psychiatric diagnosis that would preclude their ability to safely participate in the study.
- •Significant cognitive impairment
- •Pregnancy
- •Breast-Feeding
- •Unable to swallow study drug (capsule)
研究组 & 干预措施
Buspirone
Two week titration up to 10 mg tablet/3 times a day for 7 days
干预措施: Buspirone (Drug)
Placebo
Two week titration up to 3 tablets/3 times a day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Dyskinesia - UDysRS
时间窗: up to 6 weeks
UDysRS total score comparison
Area Under the Curve - Dyskinesia - Forceplate
时间窗: 6 hour levodopa dose cycle
forceplate measurements of levodopa induced dyskinesia taken every 1/2 hour for 6 hours.
Adverse Events
时间窗: up to 6 weeks
Adverse Events Monitoring/Frequency
次要结局
未报告次要终点
研究者
Kathryn Anne Chung
Associate Professor - Neurology
Oregon Health and Science University