Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
NCT ID: NCT01328002
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
116 participants
INTERVENTIONAL
2011-04-30
2012-08-31
Brief Summary
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Detailed Description
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* Followed by randomization to 8-weeks double blind treatment period for eligible patients
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Milnacipran
oral administration, twice daily dosing
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
Placebo
oral administration, twice daily dosing
Placebo
matching placebo tablets daily
Interventions
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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
Placebo
matching placebo tablets daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
13 Years
17 Years
ALL
No
Sponsors
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Cypress Bioscience, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia M D'Astoli, LPN
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 040
Birmingham, Alabama, United States
Forest Investigative Site 068
Birmingham, Alabama, United States
Forest Investigative Site 033
Bullhead City, Arizona, United States
Forest Investigative Site 012
Fresno, California, United States
Forest Investigative Site 045
Fresno, California, United States
Forest Investigative Site 051
Fresno, California, United States
Forest Investigative Site 035
Orange, California, United States
Forest Investigative Site 053
Orange, California, United States
Forest Investigative Site 050
Sacramento, California, United States
Forest Investigative Site 034
Colorado Springs, Colorado, United States
Forest Investigative Site 047
Cromwell, Connecticut, United States
Forest Investigative Site 061
Gainesville, Florida, United States
Forest Investigative Site 041
Orange City, Florida, United States
Forest Investigative Site 059
Orlando, Florida, United States
Forest Investigative Site 014
Spring Hill, Florida, United States
Forest Investigative Site 055
West Palm Beach, Florida, United States
Forest Investigative Site 058
Blue Ridge, Georgia, United States
Forest Investigative Site 031
Savannah, Georgia, United States
Forest Investigative Site 022
Chicago, Illinois, United States
Forest Investigative Site 010
Peoria, Illinois, United States
Forest Investigative Site 005
Indianapolis, Indiana, United States
Forest Investigative Site 017
Louisville, Kentucky, United States
Forest Investigative Site 009
Ann Arbor, Michigan, United States
Forest Investigative Site 024
Rochester Hills, Michigan, United States
Forest Investigative Site 036
Stevensville, Michigan, United States
Forest Investigative Site 049
Whitehouse Station, New Jersey, United States
Forest Investigative Site 018
Albuquerque, New Mexico, United States
Forest Investigative Site 062
Raleigh, North Carolina, United States
Forest Investigative Site 052
Winston-Salem, North Carolina, United States
Forest Investigative Site 038
Akron, Ohio, United States
Forest Investigative Site 016
Cincinnati, Ohio, United States
Forest Investigative Site 015
Dayton, Ohio, United States
Forest Investigative Site 019
Middleburg Heights, Ohio, United States
Forest Investigative Site 001
Oklahoma City, Oklahoma, United States
Forest Investigative Site 027
Oklahoma City, Oklahoma, United States
Forest Investigative Site 066
Mechanicsburg, Pennsylvania, United States
Forest Investigative Site 054
Philadelphia, Pennsylvania, United States
Forest Investigative Site 046
Greer, South Carolina, United States
Forest Investigative Site 023
Austin, Texas, United States
Forest Investigative Site 003
San Antonio, Texas, United States
Forest Investigative Site 042
San Antonio, Texas, United States
Forest Investigative Site 025
Clinton, Utah, United States
Forest Investigative Site 013
Salt Lake City, Utah, United States
Forest Investigative Site 021
Lynchburg, Virginia, United States
Forest Investigative Site 006
Bellevue, Washington, United States
Forest Investigative Site 063
Seattle, Washington, United States
Forest Investigative Site 004
Racine, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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MLN-MD-14
Identifier Type: -
Identifier Source: org_study_id
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