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

This study has been terminated.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01328002
First received: March 31, 2011
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Primary Fibromyalgia Syndrome
Drug: Milnacipran
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328002

  Hide Study Locations
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 053
Orange, California, United States, 92868
Forest Investigative Site 035
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.
Investigators
Study Director: Patricia M D'Astoli, LPN Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01328002     History of Changes
Other Study ID Numbers: MLN-MD-14
Study First Received: March 31, 2011
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 28, 2014