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

This study has been terminated.
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: March 31, 2011
Last updated: August 23, 2012
Last verified: August 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

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 ]

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 ]

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

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
  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 identifier: NCT01328002

  Show 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Patricia M D'Astoli, LPN Forest Laboratories
  More Information

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
Study First Received: March 31, 2011
Last Updated: August 23, 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 processed this record on May 25, 2017