Study of Fibromyalgia Treated With Milnacipran

NCT01125423 | Completed Phase 4

• 1 other identifier: MIL2009-FFMS
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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. 1.The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
2. 2.Fibromyalgia patients may have different sites of innervation.
3. 3.Milnacipran may have a therapeutic effect on some fibromyalgia patients.
4. 4.Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.

Conditions

Fibromyalgia

Keywords

Female; age 18 to 70

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Study Arms (2)

Subjects with Fibromyalgia

ACTIVE COMPARATOR

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; Procedure: Skin biopsy

Control subjects without Fibromyalgia

OTHER

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

Procedure: Skin biopsy

Interventions

Milnacipran DRUG

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.

Also known as: Savella

Subjects with Fibromyalgia

Skin Biopsy PROCEDURE

Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.

Control subjects without Fibromyalgia; Subjects with Fibromyalgia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• Forest Laboratories: collaborator

Study Sites (1)

Upstate Clinical Research, LLC

Albany, New York, 12205, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Charles E. Argoff, MD

  Neurosciences Institute, Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)