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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01331109
Recruitment Status : Terminated
First Posted : April 7, 2011
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE March 31, 2011
First Posted Date  ICMJE April 7, 2011
Results First Submitted Date  ICMJE July 31, 2013
Results First Posted Date  ICMJE September 30, 2013
Last Update Posted Date September 30, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
Adverse Events [ Time Frame: Baseline (Visit 1) to Week 53 (Visit 9) ]
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 31, 2013)
  • 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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Official Title  ICMJE A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Fibromyalgia
Intervention  ICMJE Drug: Milnacipran
maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
Study Arms  ICMJE Experimental: Milnacipran
oral administration, twice daily dosing
Intervention: Drug: Milnacipran
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2011)
200
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01331109
Other Study ID Numbers  ICMJE MLN-MD-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Cypress Bioscience, Inc.
Investigators  ICMJE
Study Director: Patricia M D'Astoli, LPN Forest Laboratories
PRS Account Forest Laboratories
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP