Study of Fibromyalgia Treated With Milnacipran
|ClinicalTrials.gov Identifier: NCT01125423|
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was: Recruiting
First Posted : May 18, 2010
Last Update Posted : June 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Milnacipran Procedure: Skin biopsy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
- Drug: Milnacipran
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.
- Efficacy of milnacipran will be determined by neurological and pain assessments [ Time Frame: 10 weeks ]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 quantative sensory testing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125423
|Contact: Charles E. Argoff, MD||518 262 firstname.lastname@example.org|
|United States, New York|
|Upstate Clinical Research, LLC||Recruiting|
|Albany, New York, United States, 12205|
|Contact: Suzanne Alterman, RN 518-533-1500 email@example.com|
|Principal Investigator: James Wymer, MD|
|Principal Investigator:||Charles E. Argoff, MD||Neurosciences Institute, Albany Medical College|