Study of Fibromyalgia Treated With Milnacipran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125423
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was:  Recruiting
First Posted : May 18, 2010
Last Update Posted : June 27, 2011
Forest Laboratories
Information provided by:
Albany Medical College

May 17, 2010
May 18, 2010
June 27, 2011
May 2010
May 2012   (Final data collection date for primary outcome measure)
Efficacy of milnacipran will be determined by neurological and pain assessments [ Time Frame: 10 weeks ]
Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantative sensory testing.
Same as current
Complete list of historical versions of study NCT01125423 on Archive Site
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Study of Fibromyalgia Treated With Milnacipran
An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran

The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are:

  1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
  2. Fibromyalgia patients may have different sites of innervation.
  3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.
  4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Milnacipran
    Subject will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control.
    Other Name: Savella
  • Procedure: Skin biopsy
    3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female age 18-70
  • fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites.
  • VAS score greater that 40mm at Screening and Randomization visits.

Exclusion Criteria:

  • History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator.
  • Allergy to lidocaine
  • Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
  • Women who are pregnant, breastfeeding or trying to become pregnant
  • Active cancer with the previous two years except treated basal cell carcinoma of the skin.
  • presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or QST
  • Co-existing conditions that can produce chronic widespread pain
  • Presence of uncontrolled or severe depression
  • Patients with Worker's Compensation, pending Worker's Compensation,
  • any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above.
  • presence of uncontrolled narrow-angle glaucoma
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Charles Argoff, MD, Neurosciences Institute, Albany Medical College
Albany Medical College
Forest Laboratories
Principal Investigator: Charles E. Argoff, MD Neurosciences Institute, Albany Medical College
Albany Medical College
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP