The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Condition: Sleep Disorders; Fibromyalgia; Sleep
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Wake Disorders; Parasomnias; Dyssomnias
Intervention: Milnacipran; Placebo
Intervention description: 50 mg twice daily; 50 mg twice daily
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Sleep disorders; Forest Laboratories; Milnacipran

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.
    

Eligibility 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.