Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

January 7, 2020 updated by: Charles Argoff, Albany Medical College

Duloxetine(Cymbalta) for Fibromyalgia: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Duloxetine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Neurosciences Institute, Albany Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female age 18-70
  • Fulfill the ACR criteria for FMS (wide spread pain for at least 3 months and pain in at least 11 of 18 tender point sites.
  • VAS score greater than 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 within 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 pending Worker's Compensation, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of duloxetine will be determined by neurological and pain assessments.
Time Frame: 9 weeks
Patients will be evaluated prior to being started on duloxetine and again at eight weeks. We will use data from VAS scores, sleep diaries and quantative sensory testing.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2010

Primary Completion (ACTUAL)

September 9, 2015

Study Completion (ACTUAL)

September 9, 2015

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUL2009-FFMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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