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Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients

NCT01294059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-07-31

No results posted yet for this study

Summary

Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical) found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake inhibitor, has been found to reduce pain and improve physical function of FM patients. However, little is known about the pain mechanisms that are affected by this medication. Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain as well as mechanical and thermal hyperalgesia of FM patients during a randomized, double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic effects to coincide or precede with effects on clinical FM pain the proposed duration for this trial is 6 weeks.

Conditions

  • Fibromyalgia

Interventions

DRUG

Milnacipran

50 mg BID Oral x 6 Weeks

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Roland Staud, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01294059 on ClinicalTrials.gov