Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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
Endpoint Classification: Safety Study
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:


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 ] [ Designated as safety issue: No ]
    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:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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

No publications provided

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 22, 2014