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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
History of Changes
  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:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

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

  Show 35 Study Locations
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 May 19, 2013