Study of Fibromyalgia Treated With Milnacipran
| Status: | Recruiting |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | May 2010 |
| Contact: | Charles E. Argoff, MD |
| Email: | czerwim@mail.amc.edu |
| Phone: | 518 262 6538 |
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.
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.
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
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