NCT00314249

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,025

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 2, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

2.2 years

First QC Date

April 11, 2006

Results QC Date

June 30, 2009

Last Update Submit

January 14, 2010

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

  • 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)

    At the end of the three-month stable dose treatment phase

  • 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."

    At the end of three-month stable dose treatment phase

Secondary Outcomes (4)

  • Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase

    Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)

  • Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.

    Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase

  • Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.

    Baseline through end of week 12 (Visit TX12)

  • Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12

    Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, oral administration, twice daily for 12 weeks

Drug: Placebo

Milnacipran

EXPERIMENTAL

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

Drug: Milnacipran 100mg

Interventions

PlaceboDRUG

Placebo, oral administration, twice daily for 12 weeks

Placebo
Milnacipran 100mgDRUG

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

Milnacipran

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

You may not qualify if:

  • psychiatric illness,
  • depression,
  • suicidal risk,
  • substance abuse,
  • pulmonary dysfunction,
  • renal impairment,
  • active cardiac disease,
  • liver disease,
  • autoimmune disease,
  • cancer,
  • inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Forest Investigative Site

Tuscaloosa, Alabama, 35406, United States

Location

Forest Investigative Site

Fresno, California, 93710, United States

Location

Forest Investigative Site

Pismo Beach, California, 93449, United States

Location

Forest Investigative Site

Vista, California, 92083, United States

Location

Forest Investigative Site

St. Petersburg, Florida, 33702, United States

Location

Forest Investigative Site

St. Petersburg, Florida, 33709, United States

Location

Forest Investigative Site

Stuart, Florida, 34996, United States

Location

Forest Investigative Site

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site

Springfield, Massachusetts, 01107, United States

Location

Forest Investigative Site

Worcester, Massachusetts, 01610, United States

Location

Forest Investigative Site

Omaha, Nebraska, 68134, United States

Location

Forest Investigative Site

Haddon Heights, New Jersey, 08035, United States

Location

Forest Investigative Site

Johnson City, New York, 13790, United States

Location

Forest Investigative Site

Syracuse, New York, 13210, United States

Location

Forest Investigative Site

Greensboro, North Carolina, 27408, United States

Location

Forest Investigative Site

Cleveland, Ohio, 44122, United States

Location

Forest Investigative Site

Columbus, Ohio, 43212, United States

Location

Forest Investigative Site

Toledo, Ohio, 43623, United States

Location

Forest Investigative Site

Eugene, Oregon, 97401, United States

Location

Forest Investigative Site

Mechanicsburg, Pennsylvania, 17055, United States

Location

Forest Investigative Site

Anderson, South Carolina, 29621, United States

Location

Forest Investigative Site

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site

Richardson, Texas, 75080, United States

Location

Forest Investigative Site

Virginia Beach, Virginia, 23454, United States

Location

Related Publications (2)

  • 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.

    PMID: 22429066DERIVED

  • 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.

    PMID: 20496365DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Robert Palmer, MD
Organization
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
robert.palmer@frx.com
1-201-427-8218

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 13, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2008

Last Updated

January 20, 2010

Results First Posted

November 2, 2009

Record last verified: 2010-01

Locations

US(24)