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Long-Term Safety and Efficacy Study 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:
NCT01331109
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 long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.


Condition Intervention Phase
Primary Fibromyalgia Syndrome
 Drug: Milnacipran
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety 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:
  • Safety will be assessed descriptively by summarizing adverse events, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) and physical exams, including Tanner staging. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 57
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); for 52 weeks.

  Eligibility

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

Inclusion Criteria:

  • Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14

Exclusion Criteria:

  • Can not tolerate a minimum milnacipran dose of 50 mg/day
  • Significant risk of suicidality
  • Pregnant and breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331109

  Show 32 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: NCT01331109     History of Changes
Other Study ID Numbers: MLN-MD-29
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

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 June 18, 2013