Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

NCT ID: NCT01127490

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-05
• Study Completion Date: 2015-09-09

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Skin biopsy

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

Intervention Type: PROCEDURE

Other Intervention Names

Cymbalta; Punch biopsy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Charles Argoff

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James P. Wymer, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Neurosciences Institute, Albany Medical College

Albany, New York, United States

Countries

United States

Other Identifiers

DUL2009-FFMS

Identifier Type: -

Identifier Source: org_study_id