A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- UPDRS
研究概览
简要总结
Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism.
The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
- •Subjects will be capable and willing to provide written informed consent prior to participation.
- •Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
- •Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
- •All other PD medications are allowed.
- •Subjects will be on a stable regimen of PD medications for 2 weeks prior to screening.
- •Subjects will be required to come with a caregiver who can accompany the subject to/from each study visit. Note: Subjects will not be allowed to drive home.
- •Female subjects will be advised to use adequate birth control throughout the study as the effects of ZLP on the fetus are unknown. Adequate birth control methods include surgical sterilization, a partner who has had a vasectomy, oral contraceptives, condom plus spermicidal cream/jelly, cervical cap plus spermicidal cream/jelly, diaphragm plus spermicidal cream/jelly, or intrauterine device (in place for at least 3 months) plus spermicidal cream/jelly. Abstinence is considered an acceptable contraceptive regimen. If a subject becomes pregnant during the study, it is important that they contact the study physician immediately.
排除标准
- •Neurodegenerative diseases.
- •Tremor predominant PD, with a score of > 2 in more than one body part.
- •Inability to tolerate being off levodopa for 12 hours.
- •A score on the Montreal Cognitive Assessment (MoCA) of less than
- •Pregnancy or lactation.
- •History of drug or alcohol abuse.
- •Known or suspected sensitivity to the investigational study drugs.
- •Other known medical or psychiatric condition that may compromise participation in the study or that judged by the site investigator could disqualify a subject from entering the study.
- •Participation in another investigational drug study whereby they received experimental drug < 30 days prior to start of this study.
- •Subjects who have undergone surgical procedures for PD but otherwise meet inclusion criteria will not be excluded a priori but evaluated on an individual basis.
研究组 & 干预措施
Sugar pill
干预措施: sugar pill (Drug)
Levodopa
干预措施: Levodopa (Drug)
Zolpidam second dose
干预措施: Zolpidem second dose (Drug)
Zolpidam first dose
干预措施: Zolpidem first dose (Drug)
结局指标
主要结局
UPDRS
时间窗: Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.
Unified Parkinson's Disease Rating Scale
次要结局
未报告次要终点
研究者
Leonard Verhagen Metman
MD
Rush University Medical Center