Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328002
Recruitment Status : Terminated
First Posted : April 4, 2011
Last Update Posted : August 24, 2012
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Fibromyalgia Syndrome Drug: Milnacipran Drug: Placebo Phase 2

Detailed Description:
  • 8 weeks open-label milnacipran period
  • Followed by randomization to 8-weeks double blind treatment period for eligible patients

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Study Start Date : April 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Milnacipran
oral administration, twice daily dosing
Drug: Milnacipran
Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined at start of study; for 8 weeks
Other Name: Savella
Placebo Comparator: Placebo
oral administration, twice daily dosing
Drug: Placebo
matching placebo tablets daily

Primary Outcome Measures :
  1. Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]

Secondary Outcome Measures :
  1. Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01328002

  Hide Study Locations
United States, Alabama
Forest Investigative Site 040
Birmingham, Alabama, United States, 35205
United States, California
Forest Investigative Site 012
Fresno, California, United States, 93710
Forest Investigative Site 045
Fresno, California, United States, 93720
Forest Investigative Site 051
Fresno, California, United States, 93721
Forest Investigative Site 035
Orange, California, United States, 92868
Forest Investigative Site 053
Orange, California, United States, 92868
Forest Investigative Site 050
Sacramento, California, United States, 95825
United States, Colorado
Forest Investigative Site 034
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Forest Investigative Site 047
Cromwell, Connecticut, United States, 06416
United States, Florida
Forest Investigative Site 041
Orange City, Florida, United States, 32763
Forest Investigative Site 061
Orlando, Florida, United States, 32806
Forest Investigative Site 014
Spring Hill, Florida, United States, 34609
Forest Investigative Site 055
West Palm Beach, Florida, United States, 33409
United States, Georgia
Forest Investigative Site 058
Blue Ridge, Georgia, United States, 30513
Forest Investigative Site 031
Savannah, Georgia, United States, 31406
United States, Illinois
Forest Investigative Site 010
Peoria, Illinois, United States, 61614
United States, Kentucky
Forest Investigative Site 017
Louisville, Kentucky, United States, 40202
United States, Michigan
Forest Investigative Site 009
Ann Arbor, Michigan, United States, 48104
Forest Investigative Site 036
Stevensville, Michigan, United States, 49127
United States, New Jersey
Forest Investigative Site 049
Whitehouse Station, New Jersey, United States, 08889
United States, North Carolina
Forest Investigative Site 062
Raleigh, North Carolina, United States, 27612
Forest Investigative Site 052
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site 038
Akron, Ohio, United States, 44308
Forest Investigative Site 016
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 015
Dayton, Ohio, United States, 45432
United States, Oklahoma
Forest Investigative Site 001
Oklahoma City, Oklahoma, United States, 73112
Forest Investigative Site 027
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Forest Investigative Site 066
Mechanicsburg, Pennsylvania, United States, 17055
Forest Investigative Site 054
Philadelphia, Pennsylvania, United States, 08046
United States, South Carolina
Forest Investigative Site 046
Greer, South Carolina, United States, 29651
United States, Texas
Forest Investigative Site 003
San Antonio, Texas, United States, 78215
Forest Investigative Site 042
San Antonio, Texas, United States, 78258
United States, Utah
Forest Investigative Site 025
Clinton, Utah, United States, 84015
Forest Investigative Site 013
Salt Lake City, Utah, United States, 84102
United States, Wisconsin
Forest Investigative Site 004
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Patricia M D'Astoli, LPN Forest Laboratories

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forest Laboratories Identifier: NCT01328002     History of Changes
Other Study ID Numbers: MLN-MD-14
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012

Keywords provided by Forest Laboratories:
Pediatric Fibromyalgia
Adolescent Fibromyalgia
loss of therapeutic response
Forest Research Institute
Serotonin Norepinephrine Reuptake Inhibitors
Randomized Withdrawal

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents