Study of Milnacipran for the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Placebo
* Drug: Milnacipran 100mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo, oral administration, twice daily for 12 weeks | Drug: Placebo<br>* Placebo, oral administration, twice daily for 12 weeks<br>|
| Experimental: Milnacipran<br>Milnacipran 100mg/day (50mg BID [twice a day]) | Drug: Milnacipran 100mg<br>* Milnacipran 100mg per day (50mg BID [twice a day])<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Syndrome Responder Status | 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) | At the end of the three-month stable dose treatment phase | 
| Composite Pain Responder Status | 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. | At the end of three-month stable dose treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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-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). | Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) | 
| Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. | 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. | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | 
| Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at 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. | Baseline through end of week 12 (Visit TX12) | 
| Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 | 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. | Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia