A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose

Completed · Phase 2

Conditions studied: Relapse-Remitting Multiple Sclerosis

In brief

This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.

Key facts

Study ID

NCT00202982

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

90

Starts

2003-08-01

Expected to finish

2005-09-01

Last updated by the study team

2010-01-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically definite MS with disease duration (from onset) of at least 6 months.
• Subjects must have had at least 1 documented relapse within the last year prior to study entry.
• Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
• Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
• Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
• Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide).
• Subjects must be between the ages of 18 and 50 years inclusive.
• Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive.
• Subjects must be willing and able to give written informed consent prior to entering the study.

You may not qualify if…

• Previous use of glatiramer acetate (oral or injectable).
• Previous use of cladribine.
• Previous use of immunosuppressive agents in the last 6 months.
• Use of experimental or investigational drugs, including I.V. immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry.
• Use of interferon agents within 60 days prior to the screening visit.
• Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
• Previous total body irradiation or total lymphoid irradiation (TLI).
• Pregnancy or breast feeding.
• Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
• Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
• A known history of sensitivity to mannitol.
• A known sensitivity to gadolinium.
• Inability to successfully undergo MRI scanning.

Where it is running

• Center for Neurologic Study — La Jolla, California, United States
• North County Neurology Associates — Oceanside, California, United States
• The MS Center of Atlanta — Atlanta, Georgia, United States
• Consultants in Neurology, Ltd — Northbrook, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• The Maryland Center for M.S. — Baltimore, Maryland, United States
• Michigan Institute of Neurological Disorders — Farmington Hills, Michigan, United States
• The Minneapolis Clinic of Neurology, LTD — Golden Valley, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• St. John's Mercy Medical Center — St Louis, Missouri, United States
• Clinical & Magnetic Resonance Research Ctr. — Albuquerque, New Mexico, United States
• MSSM - Corinne Goldsmith Dickinson Center for MS — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Allegheny Neurological Associates — Pittsburgh, Pennsylvania, United States
• University of Tennessee — Memphis, Tennessee, United States
• VAMC — Salt Lake City, Utah, United States
• MS Hub Medical Group — Seattle, Washington, United States
• Neurology & Neurosurgery — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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