The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Awakenings After Sleep Onset (NAASO)
研究概览
简要总结
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.
详细描述
The sleep disturbance in fibromyalgia is characterized as non-restorative in nature, and is defined as a feeling of light sleep, independent of duration, and as non-refreshing. As such, these patients wake up in the morning and complain of stiffness and overall aching of the body.
It is well known that reciprocal relationship exists between sleep and pain, with sleep disturbances being an important contributor to morbidity in fibromyalgia. Milnacipran, a selective serotonin norepinephrine receptor inhibitor (SNRI), was approved by the Food and Drug Administration (FDA) for the management of fibromyalgia. Although milnacipran has extensively been studied in fibromyalgia patients, but there is no objective measure, i.e., the use of overnight polysomnography, to determine its effects on sleep.
The study was undertaken to evaluate the effects of milnacipran on PSG determined measures of sleep in patients with fibromyalgia. The study also evaluated the impact of milnacipran on subjective measures of sleep and fibromyalgia symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men or women at least 18 years or older
- •Diagnosis of fibromyalgia
- •Clinically significant sleep disturbance, defined as difficulty in maintaining sleep (wake after sleep onset and arousal index) at least three times per week for at least one month
- •Understand and willing to cooperate with the study procedures
- •Maintain a normal sleep schedule, with daytime-awake and nighttime-sleep schedule, with customary bedtime between 9 PM and midnight, and rise time 5 AM and 9 AM
- •Patients who are able to speak, read, and understand English language and able to follow the study protocol, and are able to sign the informed consent
排除标准
- •Subject has any of the following medical conditions:
- •Liver disease, blood disorder, autoimmune disease, endocrine, cardiovascular, hypertension, renal, hepatic, gastrointestinal, or neurological disorder, active peptic ulcer or inflammatory bowel disease
- •Significant sleep apnea
- •Periodic leg movement disorder (PLMD) or restless legs syndrome (RLS)
- •Any form of severe psychiatric illness, moderate to severe depression, including significant risk of suicide
- •Patients with uncontrolled glaucoma
- •Inability to discontinue the prohibited medications
- •Female of childbearing potential not using birth control measures; or lactating.
- •History of alcohol, narcotic, benzodiazepines or other substance abuse within the past one year.
- •Patient on prohibited medication will include but not limited to:
- •Anxiolytics, anti-convulsants, antipsychotics, lithium, barbiturates, anti-histamines, monoamine oxidase inhibitors, or medications that affect sleep
- •Any prescription or over the counter stimulants
- •Medications that are contraindicated with the use of milnacipran
- •Excessive caffeine use, defined as a consumption of more than 500 mg of caffeine or other xanthines, smoking >1/2 a pack/day or alcohol use >14 units/week
- •History of allergy to milnacipran.
研究组 & 干预措施
milnacipran
Drug: milnacipran 7-day dose escalation, 28- day treatment with milnacipran 50 mg and 7-day taper period before or after crossover to placebo
干预措施: Milnacipran (Drug)
placebo
Drug: placebo 45-day placebo treatment before or after crossover to milnacipran
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Awakenings After Sleep Onset (NAASO)
时间窗: 4-Week maintenance treatment with milnacipran and placebo
Number of awakenings after defined sleep onset until lights on.
Sleep Efficiency (SE)
时间窗: 4-Week maintenance treatment with milnacipran and placebo
Percentage of time spent asleep while in bed
Wake After Sleep Onset (WASO)
时间窗: 4-Week maintenance treatment with milnacipran and placebo
Wake time after defined sleep onset until lights on.
次要结局
- Latency to Persistent Sleep Onset (LPS)(4-Week treatment with milnacipran and placebo)
- Total Sleep Time (TST)(4-Week treatment with milnacipran and placebo)
- Arousal Index (AI)(4-Week treatment with milnacipran and placebo)
- Slow Wave Sleep (SWS)(4-Week treatment with milnacipran and placebo)
- Sleep Problem Index 2, Medical Outcomes Study Sleep Scale (MOS-SS)(4-Week treatment with milnacipran and placebo)
- Sleep Quality Scale(4-Week treatment with milnacipran and placebo)
- Fatigue Severity Scale (FSS) Total Score(4-Week treatment with milnacipran and placebo)
- Fibromyalgia Impact Questionnaire (FIQ) Total Score(4-Week treatment with milnacipran and placebo)
- Brief Pain Inventory (BPI) Mean Severity Score(4-Week treatment with milnacipran and placebo)
- Brief Pain Inventory (BPI) Mean Interference Score(4-Week treatment with milnacipran and placebo)
研究者
Mansoor Ahmed M.D.
Medical Director
Cleveland Sleep Research Center