The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Cleveland Sleep Research Center
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Mansoor Ahmed M.D., Cleveland Sleep Research Center
ClinicalTrials.gov Identifier:
NCT01234675
First received: November 3, 2010
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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 proposed study is aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized, double-blind, placebo controlled, two way crossover PSG study to explore the effects of milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or matching placebo.


Condition Intervention Phase
Sleep Disorders
Fibromyalgia
Sleep
Drug: Milnacipran
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Cleveland Sleep Research Center:

Primary Outcome Measures:
  • Overnight polysomnography to measure sleep disturbance [ Time Frame: Overnight PSG week 6, week 14 ] [ Designated as safety issue: No ]
    Change in Sleep measures at week 6 of the treatment period I; and week 14 for treatment period II


Secondary Outcome Measures:
  • Subjective measures with change in sleep and change in pain measures [ Time Frame: assessments made at week 1, week 6, week 14 ] [ Designated as safety issue: No ]

    Subjective assessments will constitute secondary endpoints and will include:

    • Clinical Global Impression Improvement of Illness Scale (CGI-I) Clinical Global Impression- Severity of Illness scale (CGI-S); Medical Outcomes study Sleep Scale (MOS-SS); Fibromyalgia impact questionnaire (FIQ); Brief Pain Inventory (BPI) score-short form; Patient Global Impression of change (PGI-C); Beck Depression Inventory (BDI; Fatigue Severity Scale (FSS; Numeric Rating Scale-Sleep (NRS-S), part of subjective sleep questionnaire



Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo/milnacipran
Drug: Placebo, then milnacipran
Drug: Milnacipran
Placebo twice daily then 50 mg milnacipran or matching
Other Name: Savella
Placebo Comparator: milnacipran/placebo
Drug: milnacipran then placebo
Drug: Milnacipran
50 mg twice daily; then matching placebo twice daily
Other Name: Savella

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 exist 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 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 is meant to explore the effects of milnacipran, versus placebo, on sleep in patients with fibromyalgia as measured by overnight PSGs. The study will also involve important domains of fibromyalgia etiology: sleep disturbance, pain, fatigue and quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 (WASO, and AI) 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 or 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 birthcontrol 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234675

Contacts
Contact: Rozina Aamir, M.S., M.B.A 440-243-8044 sleepresearchcenter@yahoo.com
Contact: Mansoor Ahmed, MD 440-239-7533 sleepresearchcenter@yahoo.com

Locations
United States, Ohio
Cleveland Sleep Research Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Rozina Aamir, MS, MBA    440-243-8044    sleepresearchcenter@yahoo.com   
Contact: Noel Cyrill, MD    440-239-7533    noelacyrill@hotmail.com   
Principal Investigator: Mansoor Ahmed, MD         
Sub-Investigator: Rozina Aamir, MS, MBA         
Sub-Investigator: Nosson S Goldfarb, MD         
Sponsors and Collaborators
Mansoor Ahmed M.D.
Forest Laboratories
Investigators
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
  More Information

No publications provided

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
Study First Received: November 3, 2010
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Cleveland Sleep Research Center:
Fibromyalgia
Sleep disorders
Forest Laboratories
Milnacipran

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Fibromyalgia
Myofascial Pain Syndromes
Dyssomnias
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on October 01, 2014