Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Neurosciences Institute, Albany Medical College

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cymbalta

skin biopsy

Procedure

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

Other names: Punch biopsy

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: May 21, 2010
Registry last updated: Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed