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The Effect of Milnacipran in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Placebo
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain and Fatigue Study Center - Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patients taking the drug Milnacipran

Patients taking the placebo

Arm Description

Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.

Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 30, 2010
Last Updated
May 31, 2016
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01108731
Brief Title
The Effect of Milnacipran in Patients With Fibromyalgia
Official Title
The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients taking the drug Milnacipran
Arm Type
Active Comparator
Arm Description
Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.
Arm Title
Patients taking the placebo
Arm Type
Placebo Comparator
Arm Description
Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Ventricular Lactate Levels in the Brain
Description
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.
Time Frame
Baseline and 2 months
Secondary Outcome Measure Information:
Title
Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).
Description
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.
Time Frame
Baseline and 2 months
Title
Change in Widespread Pain
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin H Natelson, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain and Fatigue Study Center - Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26335989
Citation
Natelson BH, Vu D, Mao X, Weiduschat N, Togo F, Lange G, Blate M, Kang G, Coplan JD, Shungu DC. Effect of Milnacipran Treatment on Ventricular Lactate in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2015 Nov;16(11):1211-9. doi: 10.1016/j.jpain.2015.08.004. Epub 2015 Aug 31.
Results Reference
derived
Links:
URL
http://www.painandfatigue.com
Description
The Pain and Fatigue Study Center

Learn more about this trial

The Effect of Milnacipran in Patients With Fibromyalgia

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