MedTrace Logo

Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

NCT01127490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

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. The investigators will then use this information to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (duloxetine) and others do not.

Duloxetine affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression. Duloxetine is approved for sale in the United States by the Food and Drug Administration (FDA) for the treatment of fibromyalgia.

Conditions

  • Fibromyalgia

Interventions

DRUG

Duloxetine

Subjects will be titrated onto Duloxetine over one week by taking 30 mg every day for seven days. Week 2 the subject will begin to take 60 mg per day until the end of the study. If the subject wishes to stop taking Duloxetine, she will be given 30 mg per day for one week for down titration.

PROCEDURE

Skin biopsy

3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • James P. Wymer, MD · 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
2010-05-05
Primary Completion
2015-09-09
Completion
2015-09-09

Countries

  • United States

Study Locations

More Related Trials

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 NCT01127490 on ClinicalTrials.gov