The Effect of Milnacipran in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108731
• Other study ID #: BIMC #212-09
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2010
• Last updated: October 13, 2014
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pain and Fatigue Study Center - Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   The Pain and Fatigue Study Center