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

Phase 4

Completed

Brief 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.

Detailed Description: * 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets, twice a day, oral administration
Milnacipran	Milnacipran	Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Primary Outcome Measures

Name	Time	Method
Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)	Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.	The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score	Change from Baseline (Week 3) to Visit 5 (Week 13)	The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).

Locations (26): Forest Investigative Site 013
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Sacramento, California, United States
Forest Investigative Site 022
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Cromwell, Connecticut, United States
Forest Investigative Site 021
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Danbury, Connecticut, United States
Forest Investigative Site 007
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Delray Beach, Florida, United States
Forest Investigative Site 008
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Ocala, Florida, United States
Forest Investigative Site 009
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Orlando, Florida, United States
Forest Investigative Site 016
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Orlando, Florida, United States
Forest Investigative Site 012
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St. Petersburg, Florida, United States
Forest Investigative Site 019
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Tampa, Florida, United States
Forest Investigative Site 006
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Atlanta, Georgia, United States
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Forest Investigative Site 013
🇺🇸Sacramento, California, United States