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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: July 31, 2013
Last verified: July 2013
  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
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:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]
    Number of Patients who experience one or more treatment emergent adverse event (TEAE)


Other Outcome Measures:
  • Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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

  • Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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

  • Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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

  • Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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

  • Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS). [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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

  • Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ] [ Designated as safety issue: Yes ]

    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


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, 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
  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 ClinicalTrials.gov identifier: NCT01331109

  Show 31 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
Results First Received: July 31, 2013
Last Updated: July 31, 2013
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
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Milnacipran
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014