The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

NCT01234675 | Completed Phase 4 Results DMC

• 1 other identifier: SAV-MD-17
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders; Fibromyalgia; Sleep

Keywords

Fibromyalgia; Sleep disorders; Forest Laboratories; Milnacipran

Outcome Measures

Primary Outcomes (3)

• Number of Awakenings After Sleep Onset (NAASO)

  Number of awakenings after defined sleep onset until lights on.

  4-Week maintenance treatment with milnacipran and placebo

• Sleep Efficiency (SE)

  Percentage of time spent asleep while in bed

  4-Week maintenance treatment with milnacipran and placebo

• Wake After Sleep Onset (WASO)

  Wake time after defined sleep onset until lights on.

  4-Week maintenance treatment with milnacipran and placebo

Secondary Outcomes (10)

• Latency to Persistent Sleep Onset (LPS)

  4-Week treatment with milnacipran and placebo

• Total Sleep Time (TST)

  4-Week treatment with milnacipran and placebo

• Arousal Index (AI)

  4-Week treatment with milnacipran and placebo

• Slow Wave Sleep (SWS)

  4-Week treatment with milnacipran and placebo

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

  4-Week treatment with milnacipran and placebo

Study Arms (2)

milnacipran

EXPERIMENTAL

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: Milnacipran

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Milnacipran DRUG

50 mg twice daily

Also known as: Savella

milnacipran

Placebo DRUG

50 mg twice daily

Also known as: Sugar pill

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoor Ahmed M.D.: lead
• Forest Laboratories: collaborator

Study Sites (1)

Cleveland Sleep Research Center

Middleburg Heights, Ohio, 44130, United States

Location

Related Publications (1)

• Ahmed M, Aamir R, Jishi Z, Scharf MB. The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study. J Clin Sleep Med. 2016 Jan;12(1):79-86. doi: 10.5664/jcsm.5400.

  PMID: 26414990 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Fibromyalgia

Interventions

Milnacipran; Sugars

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Limitations and Caveats

A well-established adaptation and re-adaptation to laboratory effects may have compromised our results. Other study biases include biases inherent in the crossover design, and a small sample size.

Results Point of Contact

• Title: Mansoor Ahmed, MD
• Organization: Cleveland Sleep Research Center

sleepresearchcenter@yahoo.com

4402438044

Study Officials

• Mansoor Ahmed, MD

  Cleveland Sleep Research Cneter

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 21, 2019
• Results First Posted: July 22, 2015

Record last verified: 2019-08

Locations

US (1)