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Study of Fibromyalgia Treated With Milnacipran

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Skin biopsy
Skin Biopsy
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Female, age 18 to 70

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Upstate Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Subjects with Fibromyalgia

Control subjects without Fibromyalgia

Arm Description

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.

Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm.

Outcomes

Primary Outcome Measures

Efficacy of milnacipran will be determined by neurological and pain assessments
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2010
Last Updated
January 7, 2020
Sponsor
Albany Medical College
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01125423
Brief Title
Study of Fibromyalgia Treated With Milnacipran
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 Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Female, age 18 to 70

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with Fibromyalgia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control subjects without Fibromyalgia
Arm Type
Other
Arm Description
Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm.
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
Intervention Type
Procedure
Intervention Name(s)
Skin Biopsy
Intervention Description
Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
Primary Outcome Measure Information:
Title
Efficacy of milnacipran will be determined by neurological and pain assessments
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles E. Argoff, MD
Organizational Affiliation
Neurosciences Institute, Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States

12. IPD Sharing Statement

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Study of Fibromyalgia Treated With Milnacipran

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