Clinical trial NCT00098124: Study of Milnacipran for the Treatment of Fibromyalgia
Official title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: NSRI
milnacipran
fibromyalgia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2004-12-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease

Primary outcomes:
measure: Composite responder analysis based on pain and patient global status, with or without physical function.
Secondary outcomes:
measure: Quality of Life
measure: Health Assessment Questionnaire (HAQ) Disability Index
measure: Fatigue, sleep and cognitive assessments
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site
state: Alabama
city: Montgomery
country: United States
facility: Forest Investigative Site
state: Alabama
city: Peoria
country: United States
facility: Forest Investigative Site
state: Arizona
city: Beverly Hills
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site
state: California
city: Spring Valley
country: United States
facility: Forest Investigative Site
state: California
city: Torrance
country: United States
facility: Forest Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Forest Investigative Site
state: Colorado
city: Danbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Stamford
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Trumball
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Forest Investigative Site
state: Florida
city: Deland
country: United States
facility: Forest Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Palm Harbor
country: United States
facility: Forest Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Forest Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site
state: Florida
city: Decatur
country: United States
facility: Forest Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site
state: Hawaii
city: Meridian
country: United States
facility: Forest Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Forest Investigative Site
state: Illinois
city: Libertyville
country: United States
facility: Forest Investigative Site
state: Illinois
city: Peoria
country: United States
facility: Forest Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site
state: Indiana
city: Lafayette
country: United States
facility: Forest Investigative Site
state: Indiana
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Columbia
country: United States
facility: Forest Investigative Site
state: Maryland
city: Frederick
country: United States
facility: Forest Investigative Site
state: Maryland
city: Newton
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Forest Investigative Site
state: Michigan
city: Flowood
country: United States
facility: Forest Investigative Site
state: Mississippi
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Forest Investigative Site
state: Montana
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Clementon
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Santa Fe
country: United States
facility: Forest Investigative Site
state: New Mexico
city: East Syracuse
country: United States
facility: Forest Investigative Site
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Fayetteville
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Bismarck
country: United States
facility: Forest Investigative Site
state: North Dakota
city: Marion
country: United States
facility: Forest Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site
state: Oklahoma
city: Bend
country: United States
facility: Forest Investigative Site
state: Oregon
city: Eugene
country: United States
facility: Forest Investigative Site
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Duncanville
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Warwick
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Orangeburg
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Bristol
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Chattanooga
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Sugarland
country: United States
facility: Forest Investigative Site
state: Texas
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Virginia Beach
country: United States
facility: Forest Investigative Site
state: Virginia
city: Bellingham
country: United States
facility: Forest Investigative Site
state: Washington
city: Everett
country: United States
facility: Forest Investigative Site
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site
state: Washington
city: Wenatchee
country: United States
facility: Forest Investigative Site
state: Washington
city: Racine
country: United States
facility: Forest Investigative Site
state: Wisconsin
Study officials:
References:
citation: Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009.