Study of Fibromyalgia Treated With Milnacipran
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Albany Medical College.
Recruitment status was: Recruiting
Information provided by:
Albany Medical College
First received: May 17, 2010
Last updated: June 23, 2011
Last verified: December 2010
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:
- The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
- Fibromyalgia patients may have different sites of innervation.
- Milnacipran may have a therapeutic effect on some fibromyalgia patients.
- Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
Procedure: Skin biopsy
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
Subject will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control.
Other Name: Savella
Procedure: Skin biopsy
3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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: NCT01125423
|Upstate Clinical Research, LLC
|Albany, New York, United States, 12205 |
Albany Medical College
||Charles E. Argoff, MD
||Neurosciences Institute, Albany Medical College
||Charles Argoff, MD, Neurosciences Institute, Albany Medical College
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 17, 2010
||June 23, 2011
||United States: Food and Drug Administration
Keywords provided by Albany Medical College:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Myofascial Pain Syndromes
Nervous System Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors