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The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Primary Purpose

Sleep Disorders, Fibromyalgia, Sleep

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Milnacipran

Placebo

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Fibromyalgia, Sleep disorders, Forest Laboratories, Milnacipran

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cleveland Sleep Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

milnacipran

placebo

Arm Description

Drug: milnacipran 7-day dose escalation, 28- day treatment with milnacipran 50 mg and 7-day taper period before or after crossover to placebo

Drug: placebo 45-day placebo treatment before or after crossover to milnacipran

Outcomes

Primary Outcome Measures

Number of Awakenings After Sleep Onset (NAASO)

Number of awakenings after defined sleep onset until lights on.

Sleep Efficiency (SE)

Percentage of time spent asleep while in bed

Wake After Sleep Onset (WASO)

Wake time after defined sleep onset until lights on.

Secondary Outcome Measures

Latency to Persistent Sleep Onset (LPS)

It is defined as time from lights out to the first consecutive 2 minutes of uninterrupted sleep.

Total Sleep Time (TST)

Total sleep of all Rapid Eye Movement (REM) and Non- Rapid Eye Movement Sleep (NTREM) from lights out to lights on.

Arousal Index (AI)

Number of arousals per hour of sleep

Slow Wave Sleep (SWS)

Time spent in stage 3 of non-rapid eye movement sleep and often referred to as deep sleep.

Sleep Problem Index 2, Medical Outcomes Study Sleep Scale (MOS-SS)

This is a subjective index derived from the medical outcomes study sleep scale (MOS-SS) scored on a 0-100 possible range with higher scores indicating more severe sleep disruption. The scale is a self-report instrument consisting of 12 items that assess perceived initiation and maintenance of sleep, respiratory problems during sleep, sleep duration, perceived adequacy of sleep and daytime somnolence.

Sleep Quality Scale

Sleep quality measure derived from daily sleep diary rating ranging from 0 ("very poor") to 10 ("excellent")

Fatigue Severity Scale (FSS) Total Score

The scale is a 9-item self-report of fatigue in the past week and scored on a 7-point scale with 1 = strongly disagree and 7 = strongly agree. Scores range from 9 to 63 with higher scores indicating higher fatigue severity. A total score greater or equal to 36 suggests fatigue.

Fibromyalgia Impact Questionnaire (FIQ) Total Score

The scale is composed of 10 items relating to fibromyalgia symptoms experienced in the past week. Score ranges from 0 to 100 with higher scores indicating a greater effect of fibromyalgia on a person's life.

Brief Pain Inventory (BPI) Mean Severity Score

The score is derived from the BPI scale and measures pain intensity in the past 24 hour. The pain severity score is derived as the average score of 4 pain items assessing pain at its "worst", "least", "average" and "now" and ranges from 0-10 with higher scores reflecting greater pain

Brief Pain Inventory (BPI) Mean Interference Score

The score is derived from the BPI scale and measures the effect of pain on functioning in the past 24 hour. It is the average score of 7 items interfering with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Score ranges from 0-10 with higher scores reflecting greater interference.

Full Information

NCT ID

NCT01234675

First Posted

November 3, 2010

Last Updated

August 7, 2019

Sponsor

Mansoor Ahmed M.D.

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01234675

Brief Title

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Official Title

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mansoor Ahmed M.D.

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

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 exists 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 Food and Drug Administration (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 was undertaken to evaluate the effects of milnacipran on PSG determined measures of sleep in patients with fibromyalgia. The study also evaluated the impact of milnacipran on subjective measures of sleep and fibromyalgia symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorders, Fibromyalgia, Sleep

Keywords

Fibromyalgia, Sleep disorders, Forest Laboratories, Milnacipran

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

milnacipran

Arm Type

Experimental

Arm Description

Drug: milnacipran 7-day dose escalation, 28- day treatment with milnacipran 50 mg and 7-day taper period before or after crossover to placebo

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Drug: placebo 45-day placebo treatment before or after crossover to milnacipran

Intervention Type

Drug

Intervention Name(s)

Milnacipran

Other Intervention Name(s)

Savella

Intervention Description

50 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

50 mg twice daily

Primary Outcome Measure Information:

Title

Number of Awakenings After Sleep Onset (NAASO)

Description

Number of awakenings after defined sleep onset until lights on.

Time Frame

4-Week maintenance treatment with milnacipran and placebo

Title

Sleep Efficiency (SE)

Description

Percentage of time spent asleep while in bed

Time Frame

4-Week maintenance treatment with milnacipran and placebo

Title

Wake After Sleep Onset (WASO)

Description

Wake time after defined sleep onset until lights on.

Time Frame

4-Week maintenance treatment with milnacipran and placebo

Secondary Outcome Measure Information:

Title

Latency to Persistent Sleep Onset (LPS)

Description

It is defined as time from lights out to the first consecutive 2 minutes of uninterrupted sleep.

Time Frame