Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
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ClinicalTrials.gov Identifier: NCT01077375 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
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Condition or disease | Intervention/treatment | Phase |
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Fibromyalgia | Drug: Placebo Drug: Milnacipran | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablets, twice a day, oral administration
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Drug: Placebo
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Experimental: Milnacipran
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
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Drug: Milnacipran
Other Name: Savella |
- Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) [ Time Frame: 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.
- Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score [ Time Frame: 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).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077375

Study Director: | Allan Spera | Forest Research Institute Inc., A Subsidiary of Forest Laboratories |
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT01077375 |
Other Study ID Numbers: |
MLN-MD-28 |
First Posted: | March 1, 2010 Key Record Dates |
Results First Posted: | January 26, 2012 |
Last Update Posted: | January 26, 2012 |
Last Verified: | December 2011 |
Milnacipran Duloxetine Switch Forest Research Institute |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Levomilnacipran Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs |