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

Relapse-Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202982
• Other study ID #: 9006
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 12, 2010
• Start date: August 2003
• Est. completion date: September 2005

Study information

• Verified date: January 2010
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapse-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• glatiramer acetate 20 mg
glatiramer acetate 20 mg
• glatiramer acetate 40 mg
glatiramer acetate 40 mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9			No