Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
1 other identifier
interventional
364
1 country
60
Brief Summary
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2008
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
February 16, 2011
CompletedFebruary 16, 2011
January 1, 2011
1 year
November 24, 2008
November 18, 2010
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Global Impression of Change (PGIC) Responder Rate at End of Study
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
End of Randomized treatment period (11 weeks)
Secondary Outcomes (1)
Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)
Study Arms (2)
Milnacipran Added
EXPERIMENTALNo Treatment Added
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
- tolerate at least 300 mg/day of pregabalin
- have an incomplete response to pregabalin treatment
You may not qualify if:
- suicidal risk
- substance abuse
- pulmonary dysfunction
- renal impairment
- active cardiac disease
- liver disease
- narrow angle glaucoma
- autoimmune disease
- cancer
- inflammatory bowel disease
- unstable endocrine disease
- prostatic enlargement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Forest Investigative Site
Birmingham, Alabama, 35205, United States
Forest Investigative Site
Mesa, Arizona, 85210, United States
Forest Investigative Site
Peoria, Arizona, 85381, United States
Forest Investigative Site
Hot Springs, Arkansas, 71913, United States
Forest Investigative Site
Anaheim, California, 92801, United States
Forest Investigative Site
Sacramento, California, 95821, United States
Forest Investigative Site
Sacramento, California, 95825, United States
Forest Investigative Site
Torrance, California, 90505, United States
Forest Investigative Site
Walnut Creek, California, 94598, United States
Forest Investigative Site
Denver, Colorado, 80239, United States
Forest Investigative Site
Cromwell, Connecticut, 06416, United States
Forest Investigative Site
Danbury, Connecticut, 06810, United States
Forest Investigative Site
Clearwater, Florida, 33765, United States
Forest Investigative Site
Daytona Beach, Florida, 32117, United States
Forest Investigative Site
Delray Beach, Florida, 33484, United States
Forest Investigative Site
Fort Myers, Florida, 33912, United States
Forest Investigative Site
Jacksonville, Florida, 32216, United States
Forest Investigative Site
Miami, Florida, 33169, United States
Forest Investigative Site
Ocala, Florida, 34471, United States
Forest Investigative Site Orl2
Orlando, Florida, 32806, United States
Forest Investigative Site
Orlando, Florida, 32806, United States
Forest Investigative Site
Ormond Beach, Florida, 32174, United States
Forest Investigative Site PP1
Pembroke Pines, Florida, 33024, United States
Forest Investigative Site PP2
Pembroke Pines, Florida, 33029, United States
Forest Investigative Site
Pismo Beach, Florida, 93449, United States
Forest Investigative Site
St. Petersburg, Florida, 33709, United States
Forest Investigative Site
Tampa, Florida, 33614, United States
Forest Investigative Site
Atlanta, Georgia, 30328, United States
Forest Investigative Site
Honolulu, Hawaii, 96814, United States
Forest Investigative Site
Couer D'Alene, Idaho, 83814, United States
Forest Investigative Site
Evansville, Indiana, 47713, United States
Forest Investigative Site
Indianapolis, Indiana, 46254, United States
Forest Investigative Site
Indianapolis, Indiana, 46260, United States
Forest Investigative Site
Baltimore, Maryland, 21208, United States
Forest Investigative Site
No. Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site
Worcester, Massachusetts, 01610, United States
Forest Investigative Site
Jackson, Mississippi, 39202, United States
Forest Investigative Site
St Louis, Missouri, 63141, United States
Forest Investigative Site
Omaha, Nebraska, 68134, United States
Forest Investigative Site
Albuquerque, New Mexico, 87108, United States
Forest Investigative Site
Syracuse, New York, 13210, United States
Forest Investigative Site
Cincinnati, Ohio, 45219, United States
Forest Investigative Site
Cleveland, Ohio, 44122, United States
Forest Investigative Site
Eugene, Oregon, 97404, United States
Forest Investigative Site
Medford, Oregon, 97504, United States
Forest Investigative Site
Portland, Oregon, 97210, United States
Forest Investigative Site
Greer, South Carolina, 29651, United States
Forest Investigative Site
Memphis, Tennessee, 38119, United States
Forest Investigative Site
Houston, Texas, 77074, United States
Forest Investigative Site
Houston, Texas, 77104, United States
Forest Investigative Site
Lake Jackson, Texas, 77566, United States
Forest Investigative Site
Salt Lake City, Utah, 84102, United States
Forest Investigative Site
Salt Lake City, Utah, 84106, United States
Forest Investigative Site
Woodstock, Vermont, 05091, United States
Forest Investigative Site
Bellevue, Washington, 98004, United States
Forest Investigative Site
Bellingham, Washington, 98226, United States
Forest Investigative Site SEA1
Seattle, Washington, 98104, United States
Forest Investigative Site SEA2
Seattle, Washington, 98104, United States
Forest Investigative Site
Spokane, Washington, 99204, United States
Forest Investigative Site
Racine, Wisconsin, 53406, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Palmer, MD
- Organization
- Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Patricia D'Astoli
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
January 1, 2010
Last Updated
February 16, 2011
Results First Posted
February 16, 2011
Record last verified: 2011-01