Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia



Status:Terminated
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:13 - 17
Updated:10/14/2017
Start Date:April 2011
End Date:August 2012

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

The purpose of this study is to evaluate the safety, tolerability, efficacy, and
pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary
fibromyalgia.

- 8 weeks open-label milnacipran period

- Followed by randomization to 8-weeks double blind treatment period for eligible patients

Inclusion Criteria:

- Diagnosis of primary fibromyalgia

- 13-17 years of age

Exclusion Criteria:

- Severe psychiatric illness

- Severe renal impairment

- Evidence of active liver disease

- Pregnant or breastfeeding

- Significant risk of suicidality

- Unable, unwilling or unadvisable to discontinue prohibited medications
We found this trial at
30
sites
Forest Investigative Site
Cromwell, Connecticut 06416
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Cromwell, CT
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Forest Investigative Site 122
Akron, Ohio 44313
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Akron, OH
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Forest Investigative Site 1892
Ann Arbor, Michigan 48106
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Ann Arbor, MI
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Forest Investigative Site 010
Birmingham, Alabama 35216
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Birmingham, AL
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Forest Investigative Site 1080
Blue Ridge, Georgia 30513
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Blue Ridge, GA
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Forest Investigative Site 005
Cincinnati, Ohio 45219
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Cincinnati, OH
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Forest Investigative Site 014
Clinton, Utah 84015
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Clinton, UT
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Forest Investigative site 077
Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Forest Investigative site 026
Dayton, Ohio 45406
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Dayton, OH
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Forest Investigative site 064
Fresno, California 93726
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Fresno, CA
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Forest Investigative site 048
Greer, South Carolina 29651
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Greer, SC
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Forest Investigative site 087
Louisville, Kentucky 40213
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Louisville, KY
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Forest Investigative Site 066
Mechanicsburg, Pennsylvania 17055
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Mechanicsburg, PA
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Forest Investigative Site
Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Forest Investigative Site 009
Orange, California 92868
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Orange, CA
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Forest Investigative Site 041
Orange City, Florida 32763
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Orange City, FL
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Forest Investigative Site 061
Orlando, Florida 32806
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Orlando, FL
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Forest Investigative Site 1869
Peoria, Illinois 61606
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Peoria, IL
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Forest Investigative Site 019
Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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Forest Investigative Site 004
Racine, Wisconsin 53406
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Racine, WI
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Forest Investigative Site
Raleigh, North Carolina 27607
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Raleigh, NC
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Forest Investigative Site
Sacramento, California 95817
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Sacramento, CA
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Forest Investigative site 100
Salt Lake City, Utah 84124
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Salt Lake City, UT
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Forest Investigative Site 062
San Antonio, Texas 78229
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San Antonio, TX
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Forest Investigative Site 1332
Savannah, Georgia 31419
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Savannah, GA
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Forest Investigative Site 014
4664 Commercial Way
Spring Hill, Florida 34609
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Spring Hill, FL
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Forest Investigative Site 1342
Stevensville, Michigan 49127
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Stevensville, MI
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Forest Investigative Site 032
West Palm Beach, Florida 33407
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West Palm Beach, FL
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Forest Investigative Site 049
Whitehouse Station, New Jersey 08889
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Whitehouse Station, NJ
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Forest Investigative site 022
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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