Clinical trial NCT00314249: Study of Milnacipran for the Treatment of Fibromyalgia
Official title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Cypress Bioscience, Inc.
First posted: 2006-04-13
Enrollment: 1025
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: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with 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,
* inflammatory bowel disease

Primary outcomes:
measure: Composite Syndrome Responder Status
timeFrame: At the end of the three-month stable dose treatment phase
measure: Composite Pain Responder Status
timeFrame: At the end of three-month stable dose treatment phase
Secondary outcomes:
measure: Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase
timeFrame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)
measure: Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.
timeFrame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase
measure: Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.
timeFrame: Baseline through end of week 12 (Visit TX12)
measure: Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12
timeFrame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Forest Investigative Site
state: Alabama
city: Fresno
country: United States
facility: Forest Investigative Site
state: California
city: Pismo Beach
country: United States
facility: Forest Investigative Site
state: California
city: Vista
country: United States
facility: Forest Investigative Site
state: California
city: St. Petersburg
country: United States
facility: Forest Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site
state: Florida
city: Stuart
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Springfield
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Omaha
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Haddon Heights
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Johnson City
country: United States
facility: Forest Investigative Site
state: New York
city: Syracuse
country: United States
facility: Forest Investigative Site
state: New York
city: Greensboro
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Forest Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site
state: Ohio
city: Eugene
country: United States
facility: Forest Investigative Site
state: Oregon
city: Mechanicsburg
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Anderson
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Richardson
country: United States
facility: Forest Investigative Site
state: Texas
city: Virginia Beach
country: United States
facility: Forest Investigative Site
state: Virginia
Study officials:
References:
citation: Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
citation: Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.