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The Effect of Milnacipran in Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01108731
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 15, 2014
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Milnacipran Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
Study Start Date : March 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Ventricular Lactate Levels in the Brain [ Time Frame: Baseline and 2 months ]
    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.


Secondary Outcome Measures :
  1. Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT). [ Time Frame: Baseline and 2 months ]
    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.

  2. Change in Widespread Pain [ Time Frame: 2 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108731


Locations
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United States, New York
Pain and Fatigue Study Center - Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: Benjamin H Natelson, MD Beth Israel Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108731    
Other Study ID Numbers: BIMC #212-09
First Posted: April 22, 2010    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: June 30, 2016
Last Verified: October 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs