Clinical trial NCT01331109: Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Official title: A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Primary Fibromyalgia
Keywords: Fibromyalgia
Pediatric Fibromyalgia
Adolescent Fibromyalgia
milnacipran
Savella
loss of therapeutic response
Forest Research Institute
Pain
Fatigue
Serotonin Norepinephrine Reuptake Inhibitors
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Cypress Bioscience, Inc.
First posted: 2011-04-07
Enrollment: 57
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse Events
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
Secondary outcomes:
Other outcomes:
measure: Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
measure: Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
measure: Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
measure: Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
measure: Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
measure: Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
timeFrame: Baseline (Visit 1) to Week 53 (Visit 9)
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 040
state: Alabama
city: Bullhead City
country: United States
facility: Forest Investigative Site 033
state: Arizona
city: Fresno
country: United States
facility: Forest Investigative Site 012
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 045
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 051
state: California
city: Orange
country: United States
facility: Forest Investigative Site 035
state: California
city: Orange
country: United States
facility: Forest Investigative Site 053
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 050
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site 034
state: Colorado
city: Spring Hill
country: United States
facility: Forest Investigative Site 014
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 055
state: Florida
city: Blue Ridge
country: United States
facility: Forest Investigative Site 058
state: Georgia
city: Peoria
country: United States
facility: Forest Investigative Site 010
state: Illinois
city: Louisville
country: United States
facility: Forest Investigative Site 017
state: Kentucky
city: Ann Arbor
country: United States
facility: Forest Investigative Site 009
state: Michigan
city: Rochester Hills
country: United States
facility: Forest Investigative Site 024
state: Michigan
city: Stevensville
country: United States
facility: Forest Investigative Site 036
state: Michigan
city: Whitehouse Station
country: United States
facility: Forest Investigative Site 049
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 018
state: New Mexico
city: Raleigh
country: United States
facility: Forest Investigative Site 062
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 052
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site 016
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 015
state: Ohio
city: Greer
country: United States
facility: Forest Investigative Site 046
state: South Carolina
city: Austin
country: United States
facility: Forest Investigative Site 023
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 003
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 042
state: Texas
city: Clinton
country: United States
facility: Forest Investigative Site 025
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site 013
state: Utah
city: Seattle
country: United States
facility: Forest Investigative Site 063
state: Washington
city: Racine
country: United States
facility: Forest Investigative Site 004
state: Wisconsin
Study officials:
affiliation: Forest Laboratories
name: Patricia M D'Astoli, LPN
role: STUDY_DIRECTOR
References:
citation: 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.