Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

NCT01127490 | Completed

• 1 other identifier: DUL2009-FFMS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Efficacy of duloxetine will be determined by neurological and pain assessments.

  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

Interventions

Duloxetine DRUG

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.

Also known as: Cymbalta

Skin biopsy PROCEDURE

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

Also known as: Punch biopsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Neurosciences Institute, Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• James P. Wymer, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 21, 2010
• Study Start: May 5, 2010
• Primary Completion: September 9, 2015
• Study Completion: September 9, 2015
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)