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Completed

NCT Number: NCT01125423

Study of Fibromyalgia Treated With 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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Upstate Clinical Research, LLC

Albany, New York, 12205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milnacipran

Drug

Subject with Fibromyalgia 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 names: Savella

skin biopsy

Procedure

Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Primary outcomes

  1. 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 quantitative sensory testing.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 18, 2010
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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