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Trial record 73 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

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
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Mansoor Ahmed M.D., Cleveland Sleep Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Disorders Fibromyalgia Sleep Drug: Milnacipran Drug: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Milnacipran
50 mg twice daily
Other Name: Savella

Placebo Comparator: placebo
Drug: placebo 45-day placebo treatment before or after crossover to milnacipran
Drug: Placebo
50 mg twice daily
Other Name: Sugar pill




Primary Outcome Measures :
  1. 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.

  2. Sleep Efficiency (SE) [ Time Frame: 4-Week maintenance treatment with milnacipran and placebo ]
    Percentage of time spent asleep while in bed

  3. Wake After Sleep Onset (WASO) [ Time Frame: 4-Week maintenance treatment with milnacipran and placebo ]
    Wake time after defined sleep onset until lights on.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Arousal Index (AI) [ Time Frame: 4-Week treatment with milnacipran and placebo ]
    Number of arousals per hour of sleep

  4. 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.

  5. 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.

  6. 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")

  7. 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.

  8. 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.

  9. 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

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women at least 18 years or older
  2. Diagnosis of fibromyalgia
  3. 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
  4. Understand and willing to cooperate with the study procedures
  5. 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
  6. 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

Exclusion Criteria:

  1. 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

  2. Significant sleep apnea
  3. Periodic leg movement disorder (PLMD) or restless legs syndrome (RLS)
  4. Any form of severe psychiatric illness, moderate to severe depression, including significant risk of suicide
  5. Patients with uncontrolled glaucoma
  6. Inability to discontinue the prohibited medications
  7. Female of childbearing potential not using birth control measures; or lactating.
  8. History of alcohol, narcotic, benzodiazepines or other substance abuse within the past one year.
  9. 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
  10. 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
  11. History of allergy to milnacipran.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States, 44130
Sponsors and Collaborators
Mansoor Ahmed M.D.
Forest Laboratories
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mansoor Ahmed M.D., Medical Director, Cleveland Sleep Research Center
ClinicalTrials.gov Identifier: NCT01234675     History of Changes
Other Study ID Numbers: SAV-MD-17
First Posted: November 4, 2010    Key Record Dates
Results First Posted: July 22, 2015
Last Update Posted: August 21, 2019
Last Verified: August 2019
Keywords provided by Mansoor Ahmed M.D., Cleveland Sleep Research Center:
Fibromyalgia
Sleep disorders
Forest Laboratories
Milnacipran
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Sleep Wake Disorders
Parasomnias
Dyssomnias
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Milnacipran
Levomilnacipran
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs