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Study of Fibromyalgia Treated With Milnacipran

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
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01125423
First received: May 17, 2010
Last updated: June 23, 2011
Last verified: December 2010
History of Changes
  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. 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.

Condition Intervention Phase
Fibromyalgia
 Drug: Milnacipran
Procedure: Skin biopsy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • Efficacy of milnacipran will be determined by neurological and pain assessments [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125423

Contacts
Contact: Charles E. Argoff, MD 518 262 6538 czerwim@mail.amc.edu

Locations
United States, New York
Upstate Clinical Research, LLC Recruiting
Albany, New York, United States, 12205
Contact: Suzanne Alterman, RN     518-533-1500     salterman@upstateneuro.com    
Principal Investigator: James Wymer, MD            
Sponsors and Collaborators
Albany Medical College
Forest Laboratories
Investigators
Principal Investigator: Charles E. Argoff, MD Neurosciences Institute, Albany Medical College
  More Information

No publications provided

Responsible Party: Charles Argoff, MD, Neurosciences Institute, Albany Medical College
ClinicalTrials.gov Identifier: NCT01125423     History of Changes
Other Study ID Numbers: MIL2009-FFMS
Study First Received: May 17, 2010
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Albany Medical College:
Female
age 18 to 70

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on May 21, 2013