Study of Fibromyalgia Treated With Milnacipran

Study Overview
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Brief Summary
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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: The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation. Fibromyalgia patients may have different sites of innervation. Milnacipran may have a therapeutic effect on some fibromyalgia patients. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Milnacipran
* Procedure: Skin biopsy
* Procedure: Skin Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects with Fibromyalgia<br>Subjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks. | Drug: Milnacipran<br>* 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.<br>* Other names: Savella;Procedure: Skin biopsy<br>* Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.<br>Procedure: Skin Biopsy<br>* Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.<br>|
| Other: Control subjects without Fibromyalgia<br>Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. | Procedure: Skin biopsy<br>* Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.<br>Procedure: Skin Biopsy<br>* Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of milnacipran will be determined by neurological and pain assessments | 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. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, age 18 to 70