The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT01234675|
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : July 22, 2015
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorders Fibromyalgia Sleep||Drug: Milnacipran Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Drug: milnacipran 7-day dose escalation, 28- day treatment with milnacipran 50 mg and 7-day taper period before or after crossover to placebo
50 mg twice daily
Other Name: Savella
Placebo Comparator: placebo
Drug: placebo 45-day placebo treatment before or after crossover to milnacipran
50 mg twice daily
Other Name: Sugar pill
- Number of Awakenings After Sleep Onset (NAASO) [ Time Frame: 4-Week maintenance treatment with milnacipran and placebo ]Number of awakenings after defined sleep onset until lights on.
- Sleep Efficiency (SE) [ Time Frame: 4-Week maintenance treatment with milnacipran and placebo ]Percentage of time spent asleep while in bed
- Wake After Sleep Onset (WASO) [ Time Frame: 4-Week maintenance treatment with milnacipran and placebo ]Wake time after defined sleep onset until lights on.
- Latency to Persistent Sleep Onset (LPS) [ Time Frame: 4-Week treatment with milnacipran and placebo ]It is defined as time from lights out to the first consecutive 2 minutes of uninterrupted sleep.
- Total Sleep Time (TST) [ Time Frame: 4-Week treatment with milnacipran and placebo ]Total sleep of all Rapid Eye Movement (REM) and Non- Rapid Eye Movement Sleep (NTREM) from lights out to lights on.
- Arousal Index (AI) [ Time Frame: 4-Week treatment with milnacipran and placebo ]Number of arousals per hour of sleep
- Slow Wave Sleep (SWS) [ Time Frame: 4-Week treatment with milnacipran and placebo ]Time spent in stage 3 of non-rapid eye movement sleep and often referred to as deep sleep.
- Sleep Problem Index 2, Medical Outcomes Study Sleep Scale (MOS-SS) [ Time Frame: 4-Week treatment with milnacipran and placebo ]This is a subjective index derived from the medical outcomes study sleep scale (MOS-SS) scored on a 0-100 possible range with higher scores indicating more severe sleep disruption. The scale is a self-report instrument consisting of 12 items that assess perceived initiation and maintenance of sleep, respiratory problems during sleep, sleep duration, perceived adequacy of sleep and daytime somnolence.
- Sleep Quality Scale [ Time Frame: 4-Week treatment with milnacipran and placebo ]Sleep quality measure derived from daily sleep diary rating ranging from 0 ("very poor") to 10 ("excellent")
- Fatigue Severity Scale (FSS) Total Score [ Time Frame: 4-Week treatment with milnacipran and placebo ]The scale is a 9-item self-report of fatigue in the past week and scored on a 7-point scale with 1 = strongly disagree and 7 = strongly agree. Scores range from 9 to 63 with higher scores indicating higher fatigue severity. A total score greater or equal to 36 suggests fatigue.
- Fibromyalgia Impact Questionnaire (FIQ) Total Score [ Time Frame: 4-Week treatment with milnacipran and placebo ]The scale is composed of 10 items relating to fibromyalgia symptoms experienced in the past week. Score ranges from 0 to 100 with higher scores indicating a greater effect of fibromyalgia on a person's life.
- Brief Pain Inventory (BPI) Mean Severity Score [ Time Frame: 4-Week treatment with milnacipran and placebo ]The score is derived from the BPI scale and measures pain intensity in the past 24 hour. The pain severity score is derived as the average score of 4 pain items assessing pain at its "worst", "least", "average" and "now" and ranges from 0-10 with higher scores reflecting greater pain
- Brief Pain Inventory (BPI) Mean Interference Score [ Time Frame: 4-Week treatment with milnacipran and placebo ]The score is derived from the BPI scale and measures the effect of pain on functioning in the past 24 hour. It is the average score of 7 items interfering with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Score ranges from 0-10 with higher scores reflecting greater interference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234675
|United States, Ohio|
|Cleveland Sleep Research Center|
|Middleburg Heights, Ohio, United States, 44130|
|Principal Investigator:||Mansoor Ahmed, MD||Cleveland Sleep Research Cneter|
|Study Director:||Rozina Aamir, MS, MBA||Cleveland Sleep Research Center|
|Study Director:||Noel Cyrill, MD||SouthWest Cleveland Sleep Center|
|Study Director:||Nosson S Goldfarb, M.D.||Cleveland Sleep Research Center|