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

NCT01014585 | Completed Phase 4 Results

• 1 other identifier: MLN-MD-27
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 58

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.

Conditions

Fibromyalgia

Keywords

Milnacipran; Pain; Durability of Effect; Loss of Therapeutic Response; Fatigue; Forest Research Institute; Savella ®

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline Visit 3 (week 5) to Visit 7 (week 17)

Secondary Outcomes (2)

• Time to Worsening in Patient Global Impression of Change (PGIC)

  From baseline Visit 3 (week 5) to Visit 7 (week 17)

• Time to Worsening in Multidimensional Assessment of Fatigue (MAF)

  From baseline Visit 3 (week 5) to Visit 7 (week 17)

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo tablets administered orally twice daily

Drug: Placebo

2

EXPERIMENTAL

Milnacipran tablets administered orally twice daily

Drug: Milnacipran

Interventions

Placebo DRUG

Placebo tablets administered orally twice daily

1

Milnacipran DRUG

Milnacipran tablets administered orally twice daily

Also known as: Savella ®

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead
• Cypress Bioscience, Inc.: collaborator

Study Sites (58)

Forest Investigative Site 062

Birmingham, Alabama, 35205, United States

Location

Forest Investigative Site 065

Birmingham, Alabama, 35209, United States

Location

Forest Investigative Site 012

Tucson, Arizona, 85704, United States

Location

Forest Investigative Site 007

Fresno, California, 93710, United States

Location

Forest Investigative Site 032

Pismo Beach, California, 93449, United States

Location

Forest Investigative Site 025

Sacramento, California, 95825, United States

Location

Forest Investigative Site 019

San Diego, California, 92108, United States

Location

Forest Investigative Site 057

Santa Ana, California, 92705, United States

Location

Forest Investigative Site 039

Vista, California, 92083, United States

Location

Forest Investigative Site 050

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 049

Danbury, Connecticut, 06810, United States

Location

Forest Investigative Site 055

Stamford, Connecticut, 06905, United States

Location

Forest Investigative Site 011

Delray Beach, Florida, 33484, United States

Location

Forest Investigative Site 013

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 016

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 043

Palm Harbor, Florida, 34684, United States

Location

Forest Investigative Site 060

Pembroke Pines, Florida, 33029, United States

Location

Forest Investigative Site 066

Atlanta, Georgia, 30319, United States

Location

Forest Investigative Site 009

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 026

Honolulu, Hawaii, 96814, United States

Location

Forest Investigative Site 056

Libertyville, Illinois, 60048, United States

Location

Forest Investigative Site 038

Peoria, Illinois, 61614, United States

Location

Forest Investigative Site 031

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 064

Frederick, Maryland, 21702, United States

Location

Forest Investigative Site 030

Newton, Massachusetts, 02462, United States

Location

Forest Investigative Site 048

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 017

Springfield, Massachusetts, 01103, United States

Location

Forest Investigative Site 008

Worcester, Massachusetts, 01610, United States

Location

Forest Investigative Site 061

Kalamazoo, Michigan, 49009, United States

Location

Forest Investigative Site 020

Jackson, Mississippi, 39202, United States

Location

Forest Investigative Site 004

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 033

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 040

Albuquerque, New Mexico, 87108, United States

Location

Forest Investigative Site 035

Great Neck, New York, 11021, United States

Location

Forest Investigative Site 014

Rochester, New York, 14618, United States

Location

Forest Investigative Site 027

Syracuse, New York, 13210, United States

Location

Forest Investigative Site 054

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 018

Greensboro, North Carolina, 27408, United States

Location

Forest Investigative Site 002

Greenville, North Carolina, 27834, United States

Location

Forest Investigative Site 024

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 042

Winston-Salem, North Carolina, 27103, United States

Location

Forest Investigative Site 003

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 005

Cleveland, Ohio, 44122, United States

Location

Forest Investigative Site 059

Columbus, Ohio, 43212, United States

Location

Forest Investigative Site 044

Eugene, Oregon, 97401, United States

Location

Forest Investigative Site 010

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 001

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 052

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 041

Portland, Oregon, 97205, United States

Location

Forest Investigative Site 051

Duncansville, Pennsylvania, 16635, United States

Location

Forest Investigative Site 046

Mechanicsburg, Pennsylvania, 17055, United States

Location

Forest Investigative Site 028

Anderson, South Carolina, 29621, United States

Location

Forest Investigative Site 021

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 006

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site 015

Chesapeake, Virginia, 23320, United States

Location

Forest Investigative Site 047

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 036

Wenatchee, Washington, 98801, United States

Location

Forest Investigative Site 063

Racine, Wisconsin, 53406, United States

Location

Related Publications (1)

• 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.

  PMID: 23953493 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Joel Trugman, MD
• Organization: Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc.

joel.trugman@frx.com

201-427-8681

Study Officials

• Joel Trugman, MD

  Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Last Updated: September 7, 2011
• Results First Posted: September 7, 2011

Record last verified: 2011-09

Locations

US (58)