Brief Summary

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Official Title: "The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Study Primary Completion Date: August 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Drug: Milnacipran
  • Placebo twice daily then 50 mg milnacipran or matching
• Drug: Milnacipran
  • 50 mg twice daily; then matching placebo twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo/milnacipran
  • Drug: Placebo, then milnacipran
• Placebo Comparator: milnacipran/placebo
  • Drug: milnacipran then placebo

Outcome Measures for this Clinical Trial

Primary Measures

• Overnight polysomnography to measure sleep disturbance
  • Time Frame: Overnight PSG week 6, week 14
    Safety Issue?: No

Secondary Measures

• Subjective measures with change in sleep and change in pain measures
  • Time Frame: assessments made at week 1, week 6, week 14
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Mansoor Ahmed M.D.
• Collaborator
  • Forest Laboratories
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Mansoor Ahmed M.D., Medical Director - Cleveland Sleep Research Center
• Overall Official(s)
  • Mansoor Ahmed, MD, Principal Investigator, Cleveland Sleep Research Cneter
  • Rozina Aamir, MS, MBA, Study Director, Cleveland Sleep Research Center
  • Noel Cyrill, MD, Study Director, SouthWest Cleveland Sleep Center
  • Nosson S Goldfarb, M.D., Study Director, Cleveland Sleep Research Center
• Overall Contact(s)
  • Rozina Aamir, M.S., M.B.A, 440-243-8044, sleepresearchcenter@yahoo.com