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
Recruitment status was Recruiting
Sponsor:
Albany Medical College
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01127490
First received: May 18, 2010
Last updated: June 21, 2011
Last verified: December 2010
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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 (Adult, Senior) |
| 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
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
| 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 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 |
ClinicalTrials.gov processed this record on September 29, 2016