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Study of Fibromyalgia Treated With Milnacipran

NCT01125423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-01-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Charles E. Argoff, MD · Neurosciences Institute, Albany Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125423 on ClinicalTrials.gov