Varenicline for the Treatment of Postural and Gait Dysfunction in Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
The purpose of this study is to determine if varenicline is effective in improving gait and balance impairment in patients with Parkinson disease.
详细描述
Parkinson disease (PD) is a clinical entity characterized by bradykinesia, rigidity, tremor, and postural instability. Current treatments primarily focus on replacement of dopamine to compensate for the degeneration of the substantia nigra pars compacta dopaminergic neuronal population. Though dopamine treats many of the motor symptoms of PD, postural instability (which often leads to falls) typically is least responsive to therapy. More recently, the degeneration of the cholinergic system arising from the pedunculopontine nucleus (PPN) in the brainstem has been implicated in gait dysfunction in PD. Striatal cholinergic inputs are supplied from the PPN both via the intralaminar complex of the thalamus and through direct inputs. The primary subtypes of cholinergic receptors present in the striatum are nicotinic and include α4β2, α6β2, and α7 receptors. Varenicline (Chantix) is a novel partial α4β2 agonist and full α7 agonist developed as an aid for smoking cessation and has been shown in initial studies to improve imbalance in patients with inherited spinocerebellar ataxia. The unique method of action of varenicline may make it an ideal drug for the treatment of balance impairment in PD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be diagnosed with Parkinson Disease (PD) by the United Kingdom (UK) Brain Bank criteria.
- •Subjects will have to be at least stage 2 on the Hoehn and Yahr staging system of PD and have a history of at least 1 fall or near fall in the last 6 months
- •Subjects must have a stable medication regimen.
- •All subjects will be over the age of 40 in an attempt to exclude inherited forms of parkinsonism.
- •Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).
排除标准
- •Hoehn and Yahr stage V subjects.
- •Subjects with a history of major psychiatric disorder, deep brain stimulation surgery, recent cerebral trauma, cardiac arrhythmia, or renal insufficiency.
- •A cardiovascular procedure in the last 5 years (eg, percutaneous transluminal coronary angioplasty) or have cardiovascular instability (including myocardial infarction or unstable angina). Other cardiovascular exclusions include uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, peripheral vascular disease with prior amputation, or severe congestive heart failure (New York Heart Association class III or IV).
- •Concurrent treatment with any monoamine oxidase inhibitors (MAOIs), bupropion (Wellbutrin), or nicotine patches.
- •Dementia or other psychiatric illness that prevents the patient from giving informed consent (Folstein Mini Mental Status Exam score less than 25).
- •Concurrent treatment with trihexyphenidyl (Artane) or benztropine mesylate (Cogentin).
- •Significant degree of dysphagia, by history.
- •Legal incapacity or limited legal capacity.
- •Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance <60 mL/min) or hepatic disease.
- •Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
- •Use of varenicline within the previous 30 days.
- •Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
- •Allergy/sensitivity to the drug or its formulations.
- •Concurrent participation in another clinical study.
- •Active substance or tobacco use or dependence.
- •Moderate or severe chronic obstructive pulmonary disease.
- •Serious illness (requiring systemic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
- •Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Varenicline
干预措施: Varenicline (Drug)
Sugar pill
干预措施: Sugar pill (Drug)
结局指标
主要结局
Berg Balance Scale
时间窗: 9 weeks
Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of the study after 8 weeks on drug. The BBS is a 14-item measure consisting of basic balance tasks, with a final score indicative of overall balance ability. The maximum score is 56 and minimum is 0. Higher scores reflect better balance.
次要结局
- Frontal Assessment Battery(9 weeks)
- Mini Mental Status Exam (MMSE)(9 weeks)
研究者
Deborah Hall, MD
MD
Rush University Medical Center