Study of Milnacipran for the Treatment of Fibromyalgia
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ClinicalTrials.gov Identifier: NCT00314249 |
Recruitment Status :
Completed
First Posted : April 13, 2006
Results First Posted : November 1, 2009
Last Update Posted : January 20, 2010
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Condition or disease | Intervention/treatment | Phase |
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Fibromyalgia | Drug: Placebo Drug: Milnacipran 100mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1025 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia. |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo, oral administration, twice daily for 12 weeks
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Drug: Placebo
Placebo, oral administration, twice daily for 12 weeks |
Experimental: Milnacipran
Milnacipran 100mg/day (50mg BID [twice a day])
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Drug: Milnacipran 100mg
Milnacipran 100mg per day (50mg BID [twice a day]) |
- Composite Syndrome Responder Status [ Time Frame: At the end of the three-month stable dose treatment phase ]Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
- Composite Pain Responder Status [ Time Frame: At the end of three-month stable dose treatment phase ]Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."
- Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase [ Time Frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) ]
Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.
PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).
- Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]
Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.
PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.
- Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. [ Time Frame: Baseline through end of week 12 (Visit TX12) ]
Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.
MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."
- Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]
Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.
SF-36 PCS: weighted summary of physical function using all 8 domains.
Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.
SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314249
United States, Alabama | |
Forest Investigative Site | |
Tuscaloosa, Alabama, United States, 35406 | |
United States, California | |
Forest Investigative Site | |
Fresno, California, United States, 93710 | |
Forest Investigative Site | |
Pismo Beach, California, United States, 93449 | |
Forest Investigative Site | |
Vista, California, United States, 92083 | |
United States, Florida | |
Forest Investigative Site | |
St. Petersburg, Florida, United States, 33702 | |
Forest Investigative Site | |
St. Petersburg, Florida, United States, 33709 | |
Forest Investigative Site | |
Stuart, Florida, United States, 34996 | |
United States, Georgia | |
Forest Investigative Site | |
Atlanta, Georgia, United States, 30328 | |
United States, Massachusetts | |
Forest Investigative Site | |
Springfield, Massachusetts, United States, 01107 | |
Forest Investigative Site | |
Worcester, Massachusetts, United States, 01610 | |
United States, Nebraska | |
Forest Investigative Site | |
Omaha, Nebraska, United States, 68134 | |
United States, New Jersey | |
Forest Investigative Site | |
Haddon Heights, New Jersey, United States, 08035 | |
United States, New York | |
Forest Investigative Site | |
Johnson City, New York, United States, 13790 | |
Forest Investigative Site | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Forest Investigative Site | |
Greensboro, North Carolina, United States, 27408 | |
United States, Ohio | |
Forest Investigative Site | |
Cleveland, Ohio, United States, 44122 | |
Forest Investigative Site | |
Columbus, Ohio, United States, 43212 | |
Forest Investigative Site | |
Toledo, Ohio, United States, 43623 | |
United States, Oregon | |
Forest Investigative Site | |
Eugene, Oregon, United States, 97401 | |
United States, Pennsylvania | |
Forest Investigative Site | |
Mechanicsburg, Pennsylvania, United States, 17055 | |
United States, South Carolina | |
Forest Investigative Site | |
Anderson, South Carolina, United States, 29621 | |
Forest Investigative Site | |
Greer, South Carolina, United States, 29651 | |
United States, Texas | |
Forest Investigative Site | |
Richardson, Texas, United States, 75080 | |
United States, Virginia | |
Forest Investigative Site | |
Virginia Beach, Virginia, United States, 23454 |
Responsible Party: | Robert Palmer, MD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT00314249 |
Other Study ID Numbers: |
MLN-MD-03 |
First Posted: | April 13, 2006 Key Record Dates |
Results First Posted: | November 1, 2009 |
Last Update Posted: | January 20, 2010 |
Last Verified: | January 2010 |
Fibromyalgia |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Levomilnacipran Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs |