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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077375
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Placebo Drug: Milnacipran Phase 4

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
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablets, twice a day, oral administration
 Drug: Placebo
  • 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.
Experimental: Milnacipran
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
 Drug: Milnacipran
  • 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.
Other Name: Savella


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
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Study Director: Allan Spera Forest Research Institute Inc., A Subsidiary of Forest Laboratories
More Information
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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
Keywords provided by Forest Laboratories:
Milnacipran
Duloxetine
Switch
Forest Research Institute
Additional relevant MeSH terms:
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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