Back to resultsStudy to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Skin biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
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
Sites / Locations
- Neurosciences Institute, Albany Medical College
Outcomes
Primary Outcome Measures
Efficacy of duloxetine will be determined by neurological and pain assessments.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01127490
Brief Title
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
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 Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2010 (Actual)
Primary Completion Date
September 9, 2015 (Actual)
Study Completion Date
September 9, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
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
Procedure
Intervention Name(s)
Skin biopsy
Other Intervention Name(s)
Punch biopsy
Intervention Description
3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand
Primary Outcome Measure Information:
Title
Efficacy of duloxetine will be determined by neurological and pain assessments.
Description
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.
Time Frame
9 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P. Wymer, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurosciences Institute, Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
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