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

Phase 2

Completed

• Conditions: Relapse-Remitting Multiple Sclerosis
• Interventions: Drug: glatiramer acetate 20 mg; Drug: glatiramer acetate 40 mg

• Registration Number: NCT00202982
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glatiramer acetate 20 mg	glatiramer acetate 20 mg	glatiramer acetate 20 mg
glatiramer acetate 40 mg	glatiramer acetate 40 mg	glatiramer acetate 40 mg

Primary Outcome Measures

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

Trial Locations

Locations (20)

The MS Center of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Michigan Institute of Neurological Disorders; 🇺🇸 Farmington Hills, Michigan, United States

Center for Neurologic Study; 🇺🇸 La Jolla, California, United States

Allegheny Neurological Associates; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Maryland Center for M.S.; 🇺🇸 Baltimore, Maryland, United States

MS Hub Medical Group; 🇺🇸 Seattle, Washington, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

The Minneapolis Clinic of Neurology, LTD; 🇺🇸 Golden Valley, Minnesota, United States

North County Neurology Associates; 🇺🇸 Oceanside, California, United States

Consultants in Neurology, Ltd; 🇺🇸 Northbrook, Illinois, United States

St. John's Mercy Medical Center; 🇺🇸 St. Louis, Missouri, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

MSSM - Corinne Goldsmith Dickinson Center for MS; 🇺🇸 New York, New York, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

VAMC; 🇺🇸 Salt Lake City, Utah, United States

Neurology & Neurosurgery; 🇺🇸 Tacoma, Washington, United States

Clinical & Magnetic Resonance Research Ctr.; 🇺🇸 Albuquerque, New Mexico, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States