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Study of Fibromyalgia Treated With Milnacipran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125423
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Charles Argoff, Albany Medical College

Brief Summary:

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 or disease Intervention/treatment Phase
Fibromyalgia Drug: Milnacipran Procedure: Skin biopsy Procedure: Skin Biopsy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Subjects with Fibromyalgia
Subjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks.
Drug: Milnacipran
Subject with Fibromyalgia 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
Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Procedure: Skin Biopsy
Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Control subjects without Fibromyalgia
Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm.
Procedure: Skin biopsy
Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Procedure: Skin Biopsy
Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.




Primary Outcome Measures :
  1. 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 quantitative sensory testing.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125423


Locations
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United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
Sponsors and Collaborators
Albany Medical College
Forest Laboratories
Investigators
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Principal Investigator: Charles E. Argoff, MD Neurosciences Institute, Albany Medical College
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Responsible Party: Charles Argoff, Principal Investigator, Albany Medical College
ClinicalTrials.gov Identifier: NCT01125423    
Other Study ID Numbers: MIL2009-FFMS
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by Charles Argoff, Albany Medical College:
Female
age 18 to 70
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs