Study of Fibromyalgia Treated With Milnacipran

NCT ID: NCT01125423

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-01-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Milnacipran

Intervention Type: 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.

Skin biopsy

Intervention Type: PROCEDURE

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

Skin Biopsy

Intervention Type: PROCEDURE

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.

Group Type: OTHER

Skin biopsy

Intervention Type: PROCEDURE

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

Skin Biopsy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

Skin biopsy

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

Skin Biopsy

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

Intervention Type: PROCEDURE

Other Intervention Names

Savella

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Charles Argoff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles E. Argoff, MD

Role: PRINCIPAL_INVESTIGATOR

Neurosciences Institute, Albany Medical College

Locations

Upstate Clinical Research, LLC

Albany, New York, United States

Countries

United States

Other Identifiers

MIL2009-FFMS

Identifier Type: -

Identifier Source: org_study_id