Study of Milnacipran for the Treatment of Fibromyalgia

Forest Laboratories1,025 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,025

Conditions

Fibromyalgia

Interventions

PlaceboDRUG

Placebo, oral administration, twice daily for 12 weeks

Milnacipran 100mgDRUG

Milnacipran 100mg per day (50mg BID \[twice a day\])

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (24)

Forest Investigative Site

Tuscaloosa, Alabama, United States

Outcomes

Primary Outcomes

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)

Time frame: 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."

Time frame: At the end of three-month stable dose treatment phase

Secondary Outcomes

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).

Time frame: 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.

Data from ClinicalTrials.gov

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