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

Completed · Phase 4 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01014585

Run by

Forest Laboratories

People needed

340

Starts

2009-11-01

Last updated by the study team

2011-09-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 065 — Birmingham, Alabama, United States
• Forest Investigative Site 012 — Tucson, Arizona, United States
• Forest Investigative Site 007 — Fresno, California, United States
• Forest Investigative Site 032 — Pismo Beach, California, United States
• Forest Investigative Site 025 — Sacramento, California, United States
• Forest Investigative Site 019 — San Diego, California, United States
• Forest Investigative Site 057 — Santa Ana, California, United States
• Forest Investigative Site 039 — Vista, California, United States
• Forest Investigative Site 050 — Cromwell, Connecticut, United States
• Forest Investigative Site 049 — Danbury, Connecticut, United States
• Forest Investigative Site 055 — Stamford, Connecticut, United States
• Forest Investigative Site 011 — Delray Beach, Florida, United States
• Forest Investigative Site 013 — Ocala, Florida, United States
• Forest Investigative Site 016 — Orlando, Florida, United States
• Forest Investigative Site 043 — Palm Harbor, Florida, United States
• Forest Investigative Site 060 — Pembroke Pines, Florida, United States
• Forest Investigative Site 066 — Atlanta, Georgia, United States
• Forest Investigative Site 009 — Atlanta, Georgia, United States
• Forest Investigative Site 026 — Honolulu, Hawaii, United States
• Forest Investigative Site 056 — Libertyville, Illinois, United States
• Forest Investigative Site 038 — Peoria, Illinois, United States
• Forest Investigative Site 031 — Evansville, Indiana, United States
• Forest Investigative Site 064 — Frederick, Maryland, United States
• Forest Investigative Site 030 — Newton, Massachusetts, United States
• Forest Investigative Site 062 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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