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

A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients

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.

Study Overview

• Status: Completed
• Conditions: Relapse-Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: glatiramer acetate 20 mg; Drug: glatiramer acetate 40 mg

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Center for Neurologic Study
    • Oceanside, California, United States, 92056
      • North County Neurology Associates
  • Georgia
    • Atlanta, Georgia, United States
      • The MS Center of Atlanta
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology, Ltd
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States
      • The Maryland Center for M.S.
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute of Neurological Disorders
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • The Minneapolis Clinic of Neurology, LTD
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • St. John's Mercy Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Clinical & Magnetic Resonance Research Ctr.
  • New York
    • New York, New York, United States, 10029
      • MSSM - Corinne Goldsmith Dickinson Center for MS
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Neurological Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • VAMC
  • Washington
    • Seattle, Washington, United States, 98101
      • MS Hub Medical Group
    • Tacoma, Washington, United States, 98405
      • Neurology & Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinically definite MS with disease duration (from onset) of at least 6 months.
2. Subjects must have had at least 1 documented relapse within the last year prior to study entry.
3. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
4. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
5. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
6. 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).
7. Subjects must be between the ages of 18 and 50 years inclusive.
8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive.
9. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

1. Previous use of glatiramer acetate (oral or injectable).
2. Previous use of cladribine.
3. Previous use of immunosuppressive agents in the last 6 months.
4. 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.
5. Use of interferon agents within 60 days prior to the screening visit.
6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
7. Previous total body irradiation or total lymphoid irradiation (TLI).
8. Pregnancy or breast feeding.
9. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
10. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
11. A known history of sensitivity to mannitol.
12. A known sensitivity to gadolinium.
13. Inability to successfully undergo MRI scanning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: glatiramer acetate 20 mg	Drug: glatiramer acetate 20 mg; glatiramer acetate 20 mg
Active Comparator: glatiramer acetate 40 mg	Drug: glatiramer acetate 40 mg; glatiramer acetate 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Chair: Jeffery Cohen, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): January 14, 2010
• Last Update Submitted That Met QC Criteria: January 12, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: 9006