A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
- •A positive response to item 14 of the UPDRS, part
- •Age range 18-80
- •Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
- •Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
- •Stable on PD medications for ≥ 3 months
排除标准
- •Intolerance to drug class
- •Mini-Mental Status Examination <26/30
- •No observable episodes of freezing of gait despite common visual cues
- •Not on stable PD medications for 3 months
- •Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
- •Current use of monoamine oxidase inhibitor (MAO-I)
- •Hypersensitivity to drug class
- •Narrow angle glaucoma
- •Pheochromocytoma
- •Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
- •Patients with uncontrolled hypertension.
- •Patients with a history of symptomatic tachyarrhythmias.
- •Presence of uncontrolled depression and suicidal ideation.
研究组 & 干预措施
Atomoxetine
Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
干预措施: ATM FOG in PD (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: week 8
Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
次要结局
未报告次要终点