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Study of Milnacipran for the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Milnacipran 100mg
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 Fibromyalgia

Eligibility Criteria

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

Inclusion Criteria: diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: psychiatric illness, depression, suicidal risk, substance abuse, pulmonary dysfunction, renal impairment, active cardiac disease, liver disease, autoimmune disease, cancer, inflammatory bowel disease

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Milnacipran

Arm Description

Placebo, oral administration, twice daily for 12 weeks

Milnacipran 100mg/day (50mg BID [twice a day])

Outcomes

Primary Outcome Measures

Composite Syndrome Responder Status
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Composite Pain Responder Status
Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."

Secondary Outcome Measures

Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase
Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time. PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.
Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time. PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. 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.
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.
Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue. MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12
Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status. SF-36 PCS: weighted summary of physical function using all 8 domains. Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status. SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.

Full Information

First Posted
April 11, 2006
Last Updated
January 14, 2010
Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00314249
Brief Title
Study of Milnacipran for the Treatment of Fibromyalgia
Official Title
A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1025 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, oral administration, twice daily for 12 weeks
Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
Milnacipran 100mg/day (50mg BID [twice a day])
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral administration, twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Milnacipran 100mg
Intervention Description
Milnacipran 100mg per day (50mg BID [twice a day])
Primary Outcome Measure Information:
Title
Composite Syndrome Responder Status
Description
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Time Frame
At the end of the three-month stable dose treatment phase
Title
Composite Pain Responder Status
Description
Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."
Time Frame
At the end of three-month stable dose treatment phase
Secondary Outcome Measure Information:
Title
Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase
Description
Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time. PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).
Time Frame
Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)
Title
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.
Description
Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time. PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. 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
Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase
Title
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.
Description
Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue. MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."
Time Frame
Baseline through end of week 12 (Visit TX12)
Title
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12
Description
Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status. SF-36 PCS: weighted summary of physical function using all 8 domains. Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status. SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.
Time Frame
Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase

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 defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: psychiatric illness, depression, suicidal risk, substance abuse, pulmonary dysfunction, renal impairment, active cardiac disease, liver disease, autoimmune disease, cancer, inflammatory bowel disease
Facility Information:
Facility Name
Forest Investigative Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Forest Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Forest Investigative Site
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Forest Investigative Site
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Forest Investigative Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Forest Investigative Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Forest Investigative Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Forest Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Forest Investigative Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Forest Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Forest Investigative Site
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Forest Investigative Site
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Forest Investigative Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Forest Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Forest Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Forest Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Forest Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Forest Investigative Site
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Forest Investigative Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Forest Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Forest Investigative Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22429066
Citation
Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
Results Reference
derived
PubMed Identifier
20496365
Citation
Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.
Results Reference
derived

Learn more about this trial

Study of Milnacipran for the Treatment of Fibromyalgia

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