Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | December 2010 |
| End Date: | December 2012 |
| Contact: | Charles E. Argoff, MD |
| Email: | argoffc@mail.amc.edu |
| Phone: | 518 262-5226 |
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
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.
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.
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
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