The Effect of Milnacipran in Patients With Fibromyalgia
|ClinicalTrials.gov Identifier: NCT01108731|
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : October 15, 2014
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Milnacipran Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Patients taking the drug Milnacipran
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|