Study of Fibromyalgia Treated With Milnacipran

January 7, 2020 updated by: Charles Argoff, Albany Medical College

An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Charles E. Argoff, MD, Neurosciences Institute, Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIL2009-FFMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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