Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
-
Drug: Duloxetine
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Charles E. Argoff, MD | 518 262-5226 | argoffc@mail.amc.edu |
United States, New York | |
Neurosciences Institute, Albany Medical College | Recruiting |
Albany, New York, United States, 12208 | |
Principal Investigator: Charles Argoff, MD |
Principal Investigator: | James P. Wymer, MD | Albany Medical College |
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 |