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Safety and Efficacy 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:
NCT01328002
First received: March 31, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes

March 31, 2011
August 23, 2012
April 2011
August 2012   (final data collection date for primary outcome measure)
Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01328002 on ClinicalTrials.gov Archive Site
Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
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.
  • 8 weeks open-label milnacipran period
  • Followed by randomization to 8-weeks double blind treatment period for eligible patients
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Fibromyalgia Syndrome
  • Drug: Milnacipran
    Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined at start of study; for 8 weeks
    Other Name: Savella
  • Drug: Placebo
    matching placebo tablets daily
  • Experimental: Milnacipran
    oral administration, twice daily dosing
    Intervention: Drug: Milnacipran
  • Placebo Comparator: Placebo
    oral administration, twice daily dosing
    Intervention: Drug: Placebo
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.
 
Terminated
118
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of primary fibromyalgia
  • 13-17 years of age

Exclusion Criteria:

  • Severe psychiatric illness
  • Severe renal impairment
  • Evidence of active liver disease
  • Pregnant or breastfeeding
  • Significant risk of suicidality
  • Unable, unwilling or unadvisable to discontinue prohibited medications
Both
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01328002
MLN-MD-14
Yes
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Patricia M D'Astoli, LPN Forest Laboratories
Forest Laboratories
August 2012

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