Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

Phase 4

Completed

Brief Summary: The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Recruitment & Eligibility

Inclusion Criteria

Currently participating in Study MLN-MD-06
Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria

Significant risk of suicide
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 12 months
Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
Active liver disease
Severe renal impairment
Platelet and bleeding disorders
Female patients who are pregnant or breastfeeding

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo tablets administered orally twice daily
2	Milnacipran	Milnacipran tablets administered orally twice daily

Primary Outcome Measures

Name	Time	Method
Time to Loss of Therapeutic Response (LTR)	From baseline Visit 3 (week 5) to Visit 7 (week 17)	Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a \< 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment

Secondary Outcome Measures

Name	Time	Method
Time to Worsening in Patient Global Impression of Change (PGIC)	From baseline Visit 3 (week 5) to Visit 7 (week 17)	Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. 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.
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)	From baseline Visit 3 (week 5) to Visit 7 (week 17)	Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).

Locations (58): Forest Investigative Site 062
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Birmingham, Alabama, United States
Forest Investigative Site 065
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Birmingham, Alabama, United States
Forest Investigative Site 012
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Tucson, Arizona, United States
Forest Investigative Site 007
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Fresno, California, United States
Forest Investigative Site 032
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Pismo Beach, California, United States
Forest Investigative Site 025
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Sacramento, California, United States
Forest Investigative Site 019
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San Diego, California, United States
Forest Investigative Site 057
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Santa Ana, California, United States
Forest Investigative Site 039
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Vista, California, United States
Forest Investigative Site 050
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Cromwell, Connecticut, United States
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Forest Investigative Site 062
🇺🇸Birmingham, Alabama, United States