Clinical trial NCT01328002: Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, 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
Randomized Withdrawal
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Cypress Bioscience, Inc.
First posted: 2011-04-04
Enrollment: 116
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
timeFrame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
Secondary outcomes:
measure: Patient Global Impression of Severity (PGIS)
timeFrame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 040
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 068
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: Cromwell
country: United States
facility: Forest Investigative Site 047
state: Connecticut
city: Gainesville
country: United States
facility: Forest Investigative Site 061
state: Florida
city: Orange City
country: United States
facility: Forest Investigative Site 041
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 059
state: Florida
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: Savannah
country: United States
facility: Forest Investigative Site 031
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 022
state: Illinois
city: Peoria
country: United States
facility: Forest Investigative Site 010
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 005
state: Indiana
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: Akron
country: United States
facility: Forest Investigative Site 038
state: Ohio
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: Middleburg Heights
country: United States
facility: Forest Investigative Site 019
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 001
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 027
state: Oklahoma
city: Mechanicsburg
country: United States
facility: Forest Investigative Site 066
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 054
state: Pennsylvania
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: Lynchburg
country: United States
facility: Forest Investigative Site 021
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site 006
state: Washington
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.