NCT01125423

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Milnacipran	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.
PROCEDURE	Skin biopsy	Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
PROCEDURE	Skin Biopsy	Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-05-18
• Last updated: 2020-01-09

Locations

1 site across 1 country: United States