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

This study has been completed.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01077375
First received: February 25, 2010
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Fibromyalgia
Drug: Placebo
Drug: Milnacipran
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).


Enrollment: 107
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077375

  Hide Study Locations
Locations
United States, California
Forest Investigative Site 013
Sacramento, California, United States, 95825
United States, Connecticut
Forest Investigative Site 022
Cromwell, Connecticut, United States, 06416
Forest Investigative Site 021
Danbury, Connecticut, United States, 06810
United States, Florida
Forest Investigative Site 007
Delray Beach, Florida, United States, 33484
Forest Investigative Site 008
Ocala, Florida, United States, 34471
Forest Investigative Site 009
Orlando, Florida, United States, 32806
Forest Investigative Site 016
Orlando, Florida, United States, 32806
Forest Investigative Site 012
St. Petersburg, Florida, United States, 33709
Forest Investigative Site 019
Tampa, Florida, United States, 33614
United States, Georgia
Forest Investigative Site 006
Atlanta, Georgia, United States, 30328
Forest Investigative Site 024
Atlanta, Georgia, United States, 30328
United States, Indiana
Forest Investigative Site 015
Evansville, Indiana, United States, 47713
United States, Massachusetts
Forest Investigative Site 005
Worchester, Massachusetts, United States, 01610
United States, Mississippi
Forest Investigative Site 010
Jackson, Mississippi, United States, 39202
United States, Missouri
Forest Investigative Site 025
St. Louis, Missouri, United States, 63141
United States, New Jersey
Forest Investigative Site 018
Willingboro, New Jersey, United States, 08046
United States, New York
Forest Investigative Site 014
Syracuse, New York, United States, 13210
United States, North Carolina
Forest Investigative Site 023
Charlotte, North Carolina, United States, 28209
United States, Ohio
Forest Investigative Site 002
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 003
Cleveland, Ohio, United States, 44122
United States, Oregon
Forest Investigative Site 001
Medford, Oregon, United States, 97504
United States, Pennsylvania
Forest Investigative Site 020
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
Forest Investigative Site 011
Greer, South Carolina, United States, 29651
United States, Utah
Forest Investigative Site 004
Salt Lake City, Utah, United States, 84102
United States, Washington
Forest Investigative Site 017
Bellevue, Washington, United States, 98007
United States, Wisconsin
Forest Investigative Site 026
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
Study Director: Allan Spera Forest Research Institute Inc., A Subsidiary of Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01077375     History of Changes
Other Study ID Numbers: MLN-MD-28
Study First Received: February 25, 2010
Results First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Milnacipran
Duloxetine
Switch
Forest Research Institute

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Duloxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on August 26, 2014