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Safety and Efficacy 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: NCT01328002
Recruitment Status : Terminated
First Posted : April 4, 2011
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
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 4, 2011
Results First Submitted Date  ICMJE August 21, 2013
Results First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE April 30, 2011
Actual Primary Completion Date August 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. [ Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16) ]
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Patient Global Impression of Severity (PGIS) [ Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16) ]
The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
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.
Detailed Description
  • 8 weeks open-label treatment period with milnacipran.
  • Followed by randomization to 8-weeks double blind treatment period for eligible patients
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Fibromyalgia
Intervention  ICMJE
  • Drug: Milnacipran

    Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.

    Oral administration, twice daily dosing

    Other Name: Savella
  • Drug: Placebo
    matching placebo tablets daily
Study Arms  ICMJE
  • Experimental: Milnacipran
    oral administration, twice daily dosing
    Intervention: Drug: Milnacipran
  • Placebo Comparator: Placebo
    oral administration, twice daily dosing
    Intervention: Drug: Placebo
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: April 23, 2019)
116
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2011)
312
Actual Study Completion Date  ICMJE August 31, 2012
Actual Primary Completion Date August 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary fibromyalgia
  • 13-17 years of age
  • To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
  • To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
  • To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
  • Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

  • Severe psychiatric illness
  • Severe renal impairment
  • Evidence of active liver disease
  • Pregnant or breastfeeding
  • Significant risk of suicidality
  • Unable, unwilling or inadvisable to discontinue prohibited medications
  • History of alcohol abuse or drug abuse or dependence, within previous year
  • Current systemic infection
  • Autoimmune disease
  • History of seizure disorder (other than febrile seizures)
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 NCT01328002
Other Study ID Numbers  ICMJE MLN-MD-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Forest Laboratories
Original Responsible Party Stephen M. Graham, PhD, Forest Research Institute
Current Study Sponsor  ICMJE Forest Laboratories
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cypress Bioscience, Inc.
Investigators  ICMJE
Study Director: Patricia M D'Astoli, LPN Forest Laboratories
PRS Account Forest Laboratories
Verification Date March 2019

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