Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2010 by Albany Medical College.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Albany Medical College

ClinicalTrials.gov Identifier:

NCT01127490

First received: May 18, 2010

Last updated: June 21, 2011

Last verified: December 2010

History of Changes

Purpose

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.

Condition	Intervention
Fibromyalgia	Drug: Duloxetine Procedure: Skin biopsy


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Biopsy Fibromyalgia

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Albany Medical College:

Primary Outcome Measures:

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.


Estimated Enrollment:	30
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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 Name: Cymbalta

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

Other Name: Punch biopsy

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127490

Contacts


Contact: Charles E. Argoff, MD	518 262-5226	argoffc@mail.amc.edu

Locations


United States, New York
Neurosciences Institute, Albany Medical College	Recruiting
Albany, New York, United States, 12208
Principal Investigator: Charles Argoff, MD

Sponsors and Collaborators

Albany Medical College

Investigators


Principal Investigator:	James P. Wymer, MD	Albany Medical College

More Information


Responsible Party:	Charles Argoff, MD, Neurosciences Institute, Albany Medical College
ClinicalTrials.gov Identifier:	NCT01127490 History of Changes
Other Study ID Numbers:	DUL2009-FFMS
Study First Received:	May 18, 2010
Last Updated:	June 21, 2011

Additional relevant MeSH terms:


Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents

ClinicalTrials.gov processed this record on June 23, 2017

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