Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

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.

Study Overview

• Status: Terminated
• Conditions: Primary Fibromyalgia
• Intervention / Treatment: Drug: Milnacipran

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Forest Investigative Site 040
  • Arizona
    • Bullhead City, Arizona, United States, 86442
      • Forest Investigative Site 033
  • California
    • Fresno, California, United States, 93710
      • Forest Investigative Site 012
    • Fresno, California, United States, 93720
      • Forest Investigative Site 045
    • Fresno, California, United States, 93721
      • Forest Investigative Site 051
    • Orange, California, United States, 92868
      • Forest Investigative Site 035
    • Orange, California, United States, 92868
      • Forest Investigative Site 053
    • Sacramento, California, United States, 95825
      • Forest Investigative Site 050
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Forest Investigative Site 034
  • Florida
    • Spring Hill, Florida, United States, 34609
      • Forest Investigative Site 014
    • West Palm Beach, Florida, United States, 33409
      • Forest Investigative Site 055
  • Georgia
    • Blue Ridge, Georgia, United States, 30513
      • Forest Investigative Site 058
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Forest Investigative Site 010
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Forest Investigative Site 017
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Forest Investigative Site 009
    • Rochester Hills, Michigan, United States, 48307
      • Forest Investigative Site 024
    • Stevensville, Michigan, United States, 49127
      • Forest Investigative Site 036
  • New Jersey
    • Whitehouse Station, New Jersey, United States, 08889
      • Forest Investigative Site 049
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Forest Investigative Site 018
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Forest Investigative Site 062
    • Winston-Salem, North Carolina, United States, 27103
      • Forest Investigative Site 052
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Forest Investigative Site 016
    • Dayton, Ohio, United States, 45432
      • Forest Investigative Site 015
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Forest Investigative Site 046
  • Texas
    • Austin, Texas, United States, 78732
      • Forest Investigative Site 023
    • San Antonio, Texas, United States, 78215
      • Forest Investigative Site 003
    • San Antonio, Texas, United States, 78258
      • Forest Investigative Site 042
  • Utah
    • Clinton, Utah, United States, 84015
      • Forest Investigative Site 025
    • Salt Lake City, Utah, United States, 84102
      • Forest Investigative Site 013
  • Washington
    • Seattle, Washington, United States, 98104
      • Forest Investigative Site 063
  • Wisconsin
    • Racine, Wisconsin, United States, 53406
      • Forest Investigative Site 004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

• Can not tolerate a minimum daily dose of 50mg milnacipran
• Significant risk of suicidality
• Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milnacipran; oral administration, twice daily dosing	Drug: Milnacipran; maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of Patients who experience one or more treatment emergent adverse event (TEAE)	Baseline (Visit 1) to Week 53 (Visit 9)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead; Level 2: Non-Specific Active Suicidal Thoughts; Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Level 5: Active Suicidal Ideation with Specific Plan and Intent	Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are: Preparatory acts or behavior; Aborted attempt; Interrupted attempt; Actual attempt; Completed suicide attempt	Baseline (Visit 1) to Week 53 (Visit 9)

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Collaborators: Cypress Bioscience, Inc.
• Investigators: Study Director: Patricia M D'Astoli, LPN, Forest Laboratories

Publications and helpful links

General Publications

• Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: April 6, 2011
• First Posted (Estimate): April 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 30, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Fatigue; Fibromyalgia; Savella; Pediatric Fibromyalgia; Adolescent Fibromyalgia; milnacipran; loss of therapeutic response; Forest Research Institute; Serotonin Norepinephrine Reuptake Inhibitors
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: MLN-MD-29