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The Effect of Milnacipran in Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01108731
First received: March 30, 2010
Last updated: October 13, 2014
Last verified: October 2014

March 30, 2010
October 13, 2014
March 2010
January 2014   (final data collection date for primary outcome measure)
Change in Ventricular Lactate Levels in the Brain [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
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.
Ventricular lactate levels in the brain will be measured via magnetic resonance spectroscopy(MRS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Study participants will be reimbursed for their time.
Complete list of historical versions of study NCT01108731 on ClinicalTrials.gov Archive Site
  • Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT). [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    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.
  • Change in Widespread Pain [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.
Cognitive function of simple motor and complex motor reflexes will be assessed via the Attention Network Test (ANT). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • 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
  • 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.
    Other Name: Placebo
  • Active Comparator: Patients taking the drug Minalcipran
    Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.
    Intervention: Drug: Milnacipran
  • Placebo Comparator: Patients taking the placebo
    Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01108731
BIMC #212-09
No
Beth Israel Medical Center
Beth Israel Medical Center
Not Provided
Principal Investigator: Benjamin H Natelson, MD Beth Israel Medical Center
Beth Israel Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP