Clinical trial NCT01014585: Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Milnacipran
Pain
Durability of Effect
Loss of Therapeutic Response
Fatigue
Forest Research Institute
Savella ®
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Cypress Bioscience, Inc.
First posted: 2009-11-17
Enrollment: 340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.


Eligibility criteria: Inclusion Criteria:

* Currently participating in Study MLN-MD-06
* Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

* Significant risk of suicide
* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
* Myocardial infarction and/or stroke within the prior 12 months
* Mean systolic blood pressure \> 180 mm Hg or mean diastolic blood pressure \> 110 mm Hg at Screening (Visit 1)
* Active liver disease
* Severe renal impairment
* Platelet and bleeding disorders
* Female patients who are pregnant or breastfeeding

Primary outcomes:
measure: Time to Loss of Therapeutic Response (LTR)
timeFrame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
Secondary outcomes:
measure: Time to Worsening in Patient Global Impression of Change (PGIC)
timeFrame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
measure: Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
timeFrame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 062
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 065
state: Alabama
city: Tucson
country: United States
facility: Forest Investigative Site 012
state: Arizona
city: Fresno
country: United States
facility: Forest Investigative Site 007
state: California
city: Pismo Beach
country: United States
facility: Forest Investigative Site 032
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 025
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 019
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 057
state: California
city: Vista
country: United States
facility: Forest Investigative Site 039
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 050
state: Connecticut
city: Danbury
country: United States
facility: Forest Investigative Site 049
state: Connecticut
city: Stamford
country: United States
facility: Forest Investigative Site 055
state: Connecticut
city: Delray Beach
country: United States
facility: Forest Investigative Site 011
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 013
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 016
state: Florida
city: Palm Harbor
country: United States
facility: Forest Investigative Site 043
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 060
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 066
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 009
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 026
state: Hawaii
city: Libertyville
country: United States
facility: Forest Investigative Site 056
state: Illinois
city: Peoria
country: United States
facility: Forest Investigative Site 038
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site 031
state: Indiana
city: Frederick
country: United States
facility: Forest Investigative Site 064
state: Maryland
city: N. Dartmouth
country: United States
facility: Forest Investigative Site 048
state: Massachusetts
city: Newton
country: United States
facility: Forest Investigative Site 030
state: Massachusetts
city: Springfield
country: United States
facility: Forest Investigative Site 017
state: Massachusetts
city: Worcester
country: United States
facility: Forest Investigative Site 008
state: Massachusetts
city: Kalamazoo
country: United States
facility: Forest Investigative Site 061
state: Michigan
city: Jackson
country: United States
facility: Forest Investigative Site 020
state: Mississippi
city: St. Louis
country: United States
facility: Forest Investigative Site 004
state: Missouri
city: Cherry Hill
country: United States
facility: Forest Investigative Site 033
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 040
state: New Mexico
city: Great Neck
country: United States
facility: Forest Investigative Site 035
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site 014
state: New York
city: Syracuse
country: United States
facility: Forest Investigative Site 027
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 054
state: North Carolina
city: Greensboro
country: United States
facility: Forest Investigative Site 018
state: North Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 002
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 024
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 042
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site 003
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site 005
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 059
state: Ohio
city: Eugene
country: United States
facility: Forest Investigative Site 044
state: Oregon
city: Eugene
country: United States
facility: Forest Investigative Site 010
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site 001
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site 052
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 041
state: Oregon
city: Duncansville
country: United States
facility: Forest Investigative Site 051
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Forest Investigative Site 046
state: Pennsylvania
city: Anderson
country: United States
facility: Forest Investigative Site 028
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site 021
state: South Carolina
city: Salt Lake City
country: United States
facility: Forest Investigative Site 006
state: Utah
city: Chesapeake
country: United States
facility: Forest Investigative Site 015
state: Virginia
city: Seattle
country: United States
facility: Forest Investigative Site 047
state: Washington
city: Wenatchee
country: United States
facility: Forest Investigative Site 036
state: Washington
city: Racine
country: United States
facility: Forest Investigative Site 063
state: Wisconsin
Study officials:
affiliation: Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc
name: Joel Trugman, MD
role: STUDY_DIRECTOR
References:
citation: Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.