Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
研究概览
简要总结
Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients.
- •Age 65 years or older.
- •Fibromyalgia diagnosed according to ACR 1990 criteria.
- •Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
- •Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.
排除标准
- •Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
- •Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
- •Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
- •Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (> 450 msec).
- •Uncontrolled narrow angle glaucoma.
- •History of seizures.
- •Use of MAO inhibitor drugs within the last 14 days.
- •Abnormal baseline liver or renal function tests.
- •Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
- •Obstructive uropathy in males.
研究组 & 干预措施
Milnacipran
Drug
干预措施: Savella (Drug)
结局指标
主要结局
Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
时间窗: 14 months
Percent change in self-reported severity of pain (averaged Visual Analog Scale scores) over 12 weeks of treatment. Rate of occurrence of adverse events necessitating drug discontinuation
次要结局
- Determine the effects of milnacipran on cognition(14 months)