Fibromyalgia Clinical Trial
Official title:
An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran
NCT number | NCT01125423 |
Other study ID # | MIL2009-FFMS |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | January 2013 |
Verified date | January 2020 |
Source | Albany Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the characteristics of the nerves and the small veins
in the skin of people with fibromyalgia. This information will then be used to identify
possible processes in the skin that may help explain why some people feel pain relief with
the study drug (milnacipran) and others do not. The investigators expect to learn more about
the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients.
The investigators hypotheses are:
1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical
and/or morphological pathology among the sensory innervation.
2. Fibromyalgia patients may have different sites of innervation.
3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.
4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to
milnacipran.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Female age 18-70 - fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites. - VAS score greater that 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 with 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 Worker's Compensation, pending 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 |
Country | Name | City | State |
---|---|---|---|
United States | Upstate Clinical Research, LLC | Albany | New York |
Lead Sponsor | Collaborator |
---|---|
Albany Medical College | Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of milnacipran will be determined by neurological and pain assessments | Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantitative sensory testing. | 10 weeks |
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