The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
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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 |
- 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
- 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 |
Inclusion Criteria:
- Men or women at least 18 years or older.
- Diagnosis of fibromyalgia
- Clinically significant sleep disturbance, defined as difficulty in maintaining sleep (WASO, and AI) 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 Criteria:
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 or 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 birthcontrol 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.
Contacts and Locations| Contact: Rozina Aamir, M.S., M.B.A | 440-243-8044 | sleepresearchcenter@yahoo.com |
| Contact: Mansoor Ahmed, MD | 440-239-7533 | sleepresearchcenter@yahoo.com |
| 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 | |
| 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:
|
Fibromyalgia Myofascial Pain Syndromes Sleep Disorders Dyssomnias Parasomnias Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders 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 May 21, 2013