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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Placebo
* Drug: Milnacipran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo tablets, twice a day, oral administration | Drug: Placebo<br>* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.<br>|
| Experimental: Milnacipran<br>Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses. | Drug: Milnacipran<br>* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper. Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.<br>* Other names: Savella;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) | 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. | Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Milnacipran, Duloxetine, Switch, Forest Research Institute