Study of Fibromyalgia Treated With Milnacipran

Albany Medical College

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

Treatments: Procedure: Skin biopsy; Procedure: Skin Biopsy; Drug: Milnacipran

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01125423

MIL2009-FFMS

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Subjects with Fibromyalgia

Active Comparator group

Description:

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.

Treatment:

Drug: Milnacipran

Procedure: Skin biopsy

Control subjects without Fibromyalgia

Other group

Description:

Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm.

Treatment:

Procedure: Skin biopsy