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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Milnacipran
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Milnacipran, Duloxetine, Switch, Forest Research Institute

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 013
  • Forest Investigative Site 022
  • Forest Investigative Site 021
  • Forest Investigative Site 007
  • Forest Investigative Site 008
  • Forest Investigative Site 009
  • Forest Investigative Site 016
  • Forest Investigative Site 012
  • Forest Investigative Site 019
  • Forest Investigative Site 006
  • Forest Investigative Site 024
  • Forest Investigative Site 015
  • Forest Investigative Site 005
  • Forest Investigative Site 010
  • Forest Investigative Site 025
  • Forest Investigative Site 018
  • Forest Investigative Site 014
  • Forest Investigative Site 023
  • Forest Investigative Site 002
  • Forest Investigative Site 003
  • Forest Investigative Site 001
  • Forest Investigative Site 020
  • Forest Investigative Site 011
  • Forest Investigative Site 004
  • Forest Investigative Site 017
  • Forest Investigative Site 026

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Milnacipran

Arm Description

Placebo tablets, twice a day, oral administration

Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
February 25, 2010
Last Updated
December 21, 2011
Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01077375
Brief Title
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Milnacipran, Duloxetine, Switch, Forest Research Institute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, twice a day, oral administration
Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
Description
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.
Time Frame
Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.
Secondary Outcome Measure Information:
Title
Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
Description
The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Time Frame
Change from Baseline (Week 3) to Visit 5 (Week 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Spera
Organizational Affiliation
Forest Research Institute Inc., A Subsidiary of Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 013
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Forest Investigative Site 022
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 021
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Forest Investigative Site 007
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Forest Investigative Site 008
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Investigative Site 009
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 016
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 012
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Forest Investigative Site 019
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Forest Investigative Site 006
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 024
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 015
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site 005
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Forest Investigative Site 010
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Forest Investigative Site 025
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 018
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Forest Investigative Site 014
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Forest Investigative Site 023
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Forest Investigative Site 002
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 003
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site 001
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site 020
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Forest Investigative Site 011
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site 004
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site 017
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 026
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States

12. IPD Sharing Statement

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

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