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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Cypress Bioscience, Inc.
• Treatments: Levomilnacipran; Milnacipran

Criteria

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