A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Parkinson's Disease Fatigue Scale
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
- •Have normal kidney function (determined at screening visit by blood sample analysis), and no active medical diagnoses associated with fatigue
- •No orthostatic symptoms (i.e. light headedness, blurred vision, and/or muscle weakness)
- •No objective orthostasis (significant drop in blood pressure when standing)
- •No supine hypertension (high blood pressure while laying down) judged to be of clinical significance by the investigator
- •Well-controlled depression
- •Stable dopaminergic medication regimen for 6 weeks prior to screening
- •No concurrent use of fludrocortisone, midodrine, or other medications that may raise blood pressure
- •PD Fatigue Scale Score of 50 or above
排除标准
- •Diagnosis of Atypical Parkinsonism (having symptoms that mimic PD without a PD diagnosis)
- •Prior Intolerance of droxidopa
- •SNRI or TCA class (both antidepressant) medications (irrespective of indication)
- •Use of activating agents (amantadine, modafinil, methylphenidate and related stimulants)
- •Significant cardiac disease history
- •Significant kidney disease history, or creatinine (a chemical found in the blood) greater than 1.5 mg/dl at baseline
- •Poorly controlled depression
- •Women who are pregnant or breastfeeding
- •Significant history of Gastro Intestinal disease that may interfere with absorption (gastric bypass, inflammatory bowel disease)
研究组 & 干预措施
1
Active group started 100 mg TID, increased by 100 mg per interval (i.e. 100 TID) every 2 days till on 600 TID, or until intolerable dose is achieved at which time the next highest dose will be maintained (increments of 100 TID will be used).
干预措施: Northera (Drug)
2
Dosing regimen identical to active group
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Parkinson's Disease Fatigue Scale
时间窗: Week 12
16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization
次要结局
- PDQ-39(Week 12)
- Epworth Sleepiness Scale(Week 12)