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Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01127490
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was:  Recruiting
First Posted : May 21, 2010
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Albany Medical College

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Duloxetine Procedure: Skin biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Fibromyalgia
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: 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.
    Other Name: Cymbalta
    Procedure: Skin biopsy
    3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand
    Other Name: Punch biopsy

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: December 2010

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