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A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Daniel Clauw, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01173055
First received: July 29, 2010
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue. Researchers want to find out if "a drug" called milnacipran can help people with fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of fibromyalgia. In this study, milnacipran will be given to find out more about how it affects pain and thinking in people with fibromyalgia.


Condition Intervention Phase
Fibromyalgia
 Drug: milnacipran, then placebo
Drug: Placebo, then milnacipran
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind,Placebo-controlled, Two-way Crossover Study to Evaluate the Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging Activation Patterns in Patients With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in pain threshold from baseline to end of treatment [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
    The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.

  • Change in pain threshold from baseline to end of treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.

  • Change in pain threshold from baseline to end of treatment [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.

  • Change in pain threshold from baseline to end of treatment. [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.


Secondary Outcome Measures:
  • Change in diffuse noxious inhibitory control (DNIC) effect from baseline to end of treatment. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Change in diffuse noxious inhibitory control (DNIC) effect from baseline to end of treatment. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change in diffuse noxious inhibitory control (DNIC) effect from baseline to end of treatment. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change in diffuse noxious inhibitory control (DNIC) effect from baseline to end of treatment. [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Change in pain tolerance from baseline to end of treatment [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Change in pain tolerance from baseline to end of treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change in pain tolerance from baseline to end of treatment [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change in pain tolerance from baseline to end of treatment [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Change in fMRI brain activation patterns during pressure stimulation from baseline to end of treatment [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Change in fMRI brain activation patterns during pressure stimulation from baseline to end of treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change in fMRI brain activation patterns during pressure stimulation from baseline to end of treatment [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change in fMRI brain activation patterns during pressure stimulation from baseline to end of treatment [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Change in descending pain modulation from baseline to end of treatment (as assessed by changes in fMRI brainstem activation patterns) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Change in descending pain modulation from baseline to end of treatment (as assessed by changes in fMRI brainstem activation patterns) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change in descending pain modulation from baseline to end of treatment (as assessed by changes in fMRI brainstem activation patterns) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change in descending pain modulation from baseline to end of treatment (as assessed by changes in fMRI brainstem activation patterns) [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Change in fMRI activation patterns during N-back procedure from baseline to end of treatment. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Change in fMRI activation patterns during N-back procedure from baseline to end of treatment. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change in fMRI activation patterns during N-back procedure from baseline to end of treatment. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Change in fMRI activation patterns during N-back procedure from baseline to end of treatment. [ Time Frame: Week 15 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran, then placebo Drug: milnacipran, then placebo
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Other Name: Savella
Experimental: Placebo, then milnacipran Drug: Placebo, then milnacipran
Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
Other Name: placebo/sugar pill

Detailed Description:

The objective of this study is to evaluate the effect of milnacipran on pain processing in patients with fibromyalgia and to assess the correlation between this effect and neural activation patterns during fMRI.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You may be eligible to take part in this study if the following are true:

    • You are between the age of 18 and 70 years
    • If you are female
    • If you are right handed
    • You have a diagnosis of fibromyalgia for at least 3 months, as defined by the American College of Rheumatology 1990 Criteria
    • You are willing to stop taking certain medicines that you may be taking on a regular basis. The researchers will discuss these medications with you in detail

Exclusion Criteria:

  • You may not be eligible take part in this study if any of the following are true for you:

    • You have problems with your heart or cardiovascular system
    • You have problems with your liver or kidneys
    • You have an autoimmune disease, or a whole-body infection like HIV or hepatitis
    • You have cancer
    • You are pregnant or breastfeeding
    • You abuse drugs or alcohol
    • You have suicidal thoughts or wishes
    • You have taken milnacipran or another study drug within the last 30 days
    • You have a medical problem not listed here that would make it unsafe for you to take part in the study
    • The research team feels that you will be unable to complete all phases of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173055

Locations
United States, Michigan
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Forest Laboratories
Investigators
Principal Investigator: Daniel Clauw, MD University of Michigan
  More Information

No publications provided

Responsible Party: Daniel Clauw, MD, Daniel Clauw, Professor of Anesthesiology, University of Michigan, University of Michigan
ClinicalTrials.gov Identifier: NCT01173055     History of Changes
Other Study ID Numbers: MD-SAV-09
Study First Received: July 29, 2010
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on May 23, 2013