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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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