The Effect of Milnacipran in Patients With Fibromyalgia
Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."|
- 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.
- 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.
|Study Start Date:||March 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Patients taking the drug Minalcipran
Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108731
|United States, New York|
|Pain and Fatigue Study Center - Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Benjamin H Natelson, MD||Beth Israel Medical Center|