Title
Study of Milnacipran for the Treatment of Fibromyalgia
A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Phase
Phase 3Lead Sponsor
Forest LaboratoriesStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
FibromyalgiaIntervention/Treatment
milnacipran ...Study Participants
1025The 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.
Placebo, oral administration, twice daily for 12 weeks
Milnacipran 100mg per day (50mg BID [twice a day])
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
| Event Type | Organ System | Event Term | Placebo | Milnacipran |
|---|
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 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 (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 (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 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."
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.
