The Effect of Milnacipran in Patients With Fibromyalgia

The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."

Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Milnacipran; Drug: Placebo

Detailed Description

Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Pain and Fatigue Study Center - Beth Israel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
• 18 through 68 years of age

Exclusion Criteria:

• Pregnant or trying to become pregnant
• Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
• Patients who do not indicate their pain levels as less than substantial despite their best care
• History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
• Presence of current depression as determined by psychiatric diagnostic interview
• Presence of brain lesion on MRI anatomical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients taking the drug Milnacipran; Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.	Drug: Milnacipran; Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.; Other Names: Savella
Placebo Comparator: Patients taking the placebo; Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.	Drug: Placebo; Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ventricular Lactate Levels in the Brain	Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.	Baseline and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).	The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.	Baseline and 2 months
Change in Widespread Pain	Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.	2 months

Collaborators and Investigators

• Sponsor: Beth Israel Medical Center
• Investigators: Principal Investigator: Benjamin H Natelson, MD, Beth Israel Medical Center

Publications and helpful links

General Publications

• Natelson BH, Vu D, Mao X, Weiduschat N, Togo F, Lange G, Blate M, Kang G, Coplan JD, Shungu DC. Effect of Milnacipran Treatment on Ventricular Lactate in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2015 Nov;16(11):1211-9. doi: 10.1016/j.jpain.2015.08.004. Epub 2015 Aug 31.

Helpful Links

• The Pain and Fatigue Study Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: BIMC #212-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No