Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Modified Fatigue Impact Scale (MFIS)
研究概览
简要总结
The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).
详细描述
Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause of disability, we currently do not have any effective treatments for this symptom. Rasagiline is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an improvement in their energy levels when on this medication. A proven treatment for PD fatigue would significantly improve the quality of life for numerous patients and their caregivers.
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, Care Provider, Investigator)
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
- •A clinical diagnosis of idiopathic PD by a movement disorders specialist. All subjects will be diagnosed using the UK Brain Bank criteria (Hughes et al., 1992).
- •Age between 40-85 years.
- •Able to sign and understand informed consent; and cognitively able to carry out the procedures in the study
- •Stable on all PD medications for at least 30 days; and psychotropic medications for at least 90 days.
- •Treatment naïve subjects who are appropriate candidates to begin MAO-inhibitor monotherapy as treatment for their PD may also be included in this study.
- •Fatigue Severity Scale ≥ 36 (KRupps et al., 1989)
排除标准
- •Clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure).
- •History of neurological illnesses other than PD or a history of a significant head trauma (involving unconsciousness).
- •Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension.
- •MRI or CT scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen.
- •Clinical diagnoses of dementia; or an MMSE score of <
- •Unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety
- •Beck's Depression Inventory score >
- •Current or prior placement of Deep Brain Stimulator.
- •Currently taking an MAO-B inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants.
- •Previously taken an MAO-B inhibitor for more than 2 weeks.
- •Hypersensitivity to rasagiline or its products
- •On mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, St. John's wort, cyclobenzaprine
- •On omeprazole, ciprofloxacin or drugs that are metabolized through CYP1A2
研究组 & 干预措施
sugar pill
Placebo tablet, 1 per day, duration is approximately 12 weeks.
干预措施: Placebo (Drug)
rasagiline
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
干预措施: Rasagiline (Drug)
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS)
时间窗: Change from baseline to week 12
The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.
次要结局
- Fatigue Severity Scale (FSS)(Change from baseline to week 12)
- Multidimensional Fatigue Inventory (MFIS)(Change from baseline to week 12)
- PD Quality of Life Scale (PDQ39)(Change from baseline to week 12)
- Paced Auditory Serial Addition Test (PASAT)(Change from baseline to week 12)
- Finger Tapping(Change from baseline to week 12)
- Hand-grip Strength(Change from baseline to week 12)