Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Completed · Phase 4 · Has a placebo group
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT01077375
- Run by
- Forest Laboratories
- People needed
- 107
- Starts
- 2010-02-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2012-01-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Forest Investigative Site 013 — Sacramento, California, United States
- Forest Investigative Site 022 — Cromwell, Connecticut, United States
- Forest Investigative Site 021 — Danbury, Connecticut, United States
- Forest Investigative Site 007 — Delray Beach, Florida, United States
- Forest Investigative Site 008 — Ocala, Florida, United States
- Forest Investigative Site 009 — Orlando, Florida, United States
- Forest Investigative Site 016 — Orlando, Florida, United States
- Forest Investigative Site 012 — St. Petersburg, Florida, United States
- Forest Investigative Site 019 — Tampa, Florida, United States
- Forest Investigative Site 006 — Atlanta, Georgia, United States
- Forest Investigative Site 024 — Atlanta, Georgia, United States
- Forest Investigative Site 015 — Evansville, Indiana, United States
- Forest Investigative Site 005 — Worchester, Massachusetts, United States
- Forest Investigative Site 010 — Jackson, Mississippi, United States
- Forest Investigative Site 025 — St Louis, Missouri, United States
- Forest Investigative Site 018 — Willingboro, New Jersey, United States
- Forest Investigative Site 014 — Syracuse, New York, United States
- Forest Investigative Site 023 — Charlotte, North Carolina, United States
- Forest Investigative Site 002 — Cincinnati, Ohio, United States
- Forest Investigative Site 003 — Cleveland, Ohio, United States
- Forest Investigative Site 001 — Medford, Oregon, United States
- Forest Investigative Site 020 — Mechanicsburg, Pennsylvania, United States
- Forest Investigative Site 011 — Greer, South Carolina, United States
- Forest Investigative Site 004 — Salt Lake City, Utah, United States
- Forest Investigative Site 017 — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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