Status:
COMPLETED
The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Lead Sponsor:
Mansoor Ahmed M.D.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Sleep Disorders
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- Men or women at least 18 years or older
- Diagnosis of fibromyalgia
- 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
- Understand and willing to cooperate with the study procedures
- 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
- 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
- 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
- Significant sleep apnea
- Periodic leg movement disorder (PLMD) or restless legs syndrome (RLS)
- Any form of severe psychiatric illness, moderate to severe depression, including significant risk of suicide
- Patients with uncontrolled glaucoma
- Inability to discontinue the prohibited medications
- Female of childbearing potential not using birth control measures; or lactating.
- History of alcohol, narcotic, benzodiazepines or other substance abuse within the past one year.
- 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
- 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
- History of allergy to milnacipran.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01234675
Start Date
November 1 2010
End Date
February 1 2014
Last Update
August 21 2019
Active Locations (1)
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1
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States, 44130