Phase 4
N=19
The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Sleep Disorders · Fibromyalgia · Sleep
Bottom Line
View on ClinicalTrials.gov: NCT01234675 ↗Enrolled (actual)
19
Serious AEs
2.6%
Results posted
Jul 2015
Primary outcome: Primary: Number of Awakenings After Sleep Onset (NAASO) — 39.5; 34.9 Awakenings — p=0.424
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Milnacipran (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mansoor Ahmed M.D.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Awakenings After Sleep Onset (NAASO) |
39.5; 34.9 | 0.424 |
| PRIMARY Sleep Efficiency (SE) |
77.1; 83.3 | 0.049 sig |
| PRIMARY Wake After Sleep Onset (WASO) |
76.2; 53.6 | 0.056 |
| SECONDARY Latency to Persistent Sleep Onset (LPS) |
41.6; 38.6 | 0.683 |
| SECONDARY Total Sleep Time (TST) |
361.7; 386.1 | 0.155 |
| SECONDARY Arousal Index (AI) |
30.2; 31.2 | 0.805 |
| SECONDARY Slow Wave Sleep (SWS) |
8.4; 9.4 | 0.844 |
| SECONDARY Sleep Problem Index 2, Medical Outcomes Study Sleep Scale (MOS-SS) |
37.8; 34.9 | 0.509 |
| SECONDARY Sleep Quality Scale |
5.2; 4.9 | 0.3 |
| SECONDARY Fatigue Severity Scale (FSS) Total Score |
41.0; 42.3 | 0.685 |
| SECONDARY Fibromyalgia Impact Questionnaire (FIQ) Total Score |
40.0; 45.3 | 0.349 |
| SECONDARY Brief Pain Inventory (BPI) Mean Severity Score |
4.1; 4.7 | 0.305 |
| SECONDARY Brief Pain Inventory (BPI) Mean Interference Score |
3.8; 4.3 | 0.425 |
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
- 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 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 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.
Data sourced from ClinicalTrials.gov (NCT01234675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.