Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

• Two weeks Duloxetine 60 mg Open-Label Period
• Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
• One week Double-Blind Down-Taper Period

Inclusion Criteria:

• Diagnosis of fibromyalgia
• Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
• Duloxetine must have been prescribed for the treatment of Fibromyalgia
• Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
• At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Exclusion Criteria:

• Suicidal risk
• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
• Myocardial infarction and/or stroke within the prior 6 months
• Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
• Substance abuse
• Pulmonary dysfunction
• Severe renal impairment
• Active cardiac disease
• Liver disease
• Uncontrolled narrow-angle glaucoma
• Autoimmune disease
• Cancer
• Inflammatory bowel disease
• Unstable endocrine disease
• Prostatic enlargement
• Female patients who are pregnant or breastfeeding