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Discontinuation Study of the Durability of Effect of Milnacipran 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, Pain, Durability of Effect, Loss of Therapeutic Response, Fatigue, Forest Research Institute, Savella ®

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently participating in Study MLN-MD-06
  • Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

  • Significant risk of suicide
  • History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
  • Myocardial infarction and/or stroke within the prior 12 months
  • Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
  • Active liver disease
  • Severe renal impairment
  • Platelet and bleeding disorders
  • Female patients who are pregnant or breastfeeding

Sites / Locations

  • Forest Investigative Site 062
  • Forest Investigative Site 065
  • Forest Investigative Site 012
  • Forest Investigative Site 007
  • Forest Investigative Site 032
  • Forest Investigative Site 025
  • Forest Investigative Site 019
  • Forest Investigative Site 057
  • Forest Investigative Site 039
  • Forest Investigative Site 050
  • Forest Investigative Site 049
  • Forest Investigative Site 055
  • Forest Investigative Site 011
  • Forest Investigative Site 013
  • Forest Investigative Site 016
  • Forest Investigative Site 043
  • Forest Investigative Site 060
  • Forest Investigative Site 066
  • Forest Investigative Site 009
  • Forest Investigative Site 026
  • Forest Investigative Site 056
  • Forest Investigative Site 038
  • Forest Investigative Site 031
  • Forest Investigative Site 064
  • Forest Investigative Site 048
  • Forest Investigative Site 030
  • Forest Investigative Site 017
  • Forest Investigative Site 008
  • Forest Investigative Site 061
  • Forest Investigative Site 020
  • Forest Investigative Site 004
  • Forest Investigative Site 033
  • Forest Investigative Site 040
  • Forest Investigative Site 035
  • Forest Investigative Site 014
  • Forest Investigative Site 027
  • Forest Investigative Site 054
  • Forest Investigative Site 018
  • Forest Investigative Site 002
  • Forest Investigative Site 024
  • Forest Investigative Site 042
  • Forest Investigative Site 003
  • Forest Investigative Site 005
  • Forest Investigative Site 059
  • Forest Investigative Site 044
  • Forest Investigative Site 010
  • Forest Investigative Site 001
  • Forest Investigative Site 052
  • Forest Investigative Site 041
  • Forest Investigative Site 051
  • Forest Investigative Site 046
  • Forest Investigative Site 028
  • Forest Investigative Site 021
  • Forest Investigative Site 006
  • Forest Investigative Site 015
  • Forest Investigative Site 047
  • Forest Investigative Site 036
  • Forest Investigative Site 063

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo tablets administered orally twice daily

Milnacipran tablets administered orally twice daily

Outcomes

Primary Outcome Measures

Time to Loss of Therapeutic Response (LTR)
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment

Secondary Outcome Measures

Time to Worsening in Patient Global Impression of Change (PGIC)
Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).

Full Information

First Posted
November 13, 2009
Last Updated
September 2, 2011
Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01014585
Brief Title
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
Official Title
A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)

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 purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Milnacipran, Pain, Durability of Effect, Loss of Therapeutic Response, Fatigue, Forest Research Institute, Savella ®

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablets administered orally twice daily
Arm Title
2
Arm Type
Experimental
Arm Description
Milnacipran tablets administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella ®
Intervention Description
Milnacipran tablets administered orally twice daily
Primary Outcome Measure Information:
Title
Time to Loss of Therapeutic Response (LTR)
Description
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment
Time Frame
From baseline Visit 3 (week 5) to Visit 7 (week 17)
Secondary Outcome Measure Information:
Title
Time to Worsening in Patient Global Impression of Change (PGIC)
Description
Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.
Time Frame
From baseline Visit 3 (week 5) to Visit 7 (week 17)
Title
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
Description
Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).
Time Frame
From baseline Visit 3 (week 5) to Visit 7 (week 17)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently participating in Study MLN-MD-06 Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1) Exclusion Criteria: Significant risk of suicide History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder Myocardial infarction and/or stroke within the prior 12 months Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1) Active liver disease Severe renal impairment Platelet and bleeding disorders Female patients who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Trugman, MD
Organizational Affiliation
Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 062
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Forest Investigative Site 065
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Forest Investigative Site 012
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Forest Investigative Site 007
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Forest Investigative Site 032
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Forest Investigative Site 025
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Forest Investigative Site 019
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 057
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Forest Investigative Site 039
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Forest Investigative Site 050
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 049
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Forest Investigative Site 055
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Forest Investigative Site 011
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Forest Investigative Site 013
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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 043
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Forest Investigative Site 060
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Forest Investigative Site 066
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30319
Country
United States
Facility Name
Forest Investigative Site 009
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 026
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Forest Investigative Site 056
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 038
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Forest Investigative Site 031
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site 064
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Forest Investigative Site 048
City
N. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site 030
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Forest Investigative Site 017
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Forest Investigative Site 008
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Forest Investigative Site 061
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Forest Investigative Site 020
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Forest Investigative Site 004
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 033
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 040
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Forest Investigative Site 035
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Forest Investigative Site 014
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site 027
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Forest Investigative Site 054
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Forest Investigative Site 018
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Forest Investigative Site 002
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Forest Investigative Site 024
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Forest Investigative Site 042
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forest Investigative Site 003
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 005
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site 059
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Forest Investigative Site 044
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Forest Investigative Site 010
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
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 052
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site 041
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Facility Name
Forest Investigative Site 051
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Forest Investigative Site 046
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Forest Investigative Site 028
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Forest Investigative Site 021
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site 006
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site 015
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Forest Investigative Site 047
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 036
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Forest Investigative Site 063
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23953493
Citation
Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.
Results Reference
derived

Learn more about this trial

Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

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