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

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ClinicalTrials.gov Identifier: NCT01328002
Recruitment Status : Terminated
First Posted : April 4, 2011
Last Update Posted : August 24, 2012
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov 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:
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
 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