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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00202982
First received: September 12, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Relapse-Remitting Multiple Sclerosis
Drug: glatiramer acetate 20 mg
Drug: glatiramer acetate 40 mg
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9 [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: August 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: glatiramer acetate 20 mg
glatiramer acetate 20 mg
Drug: glatiramer acetate 20 mg
glatiramer acetate 20 mg
Active Comparator: glatiramer acetate 40 mg
glatiramer acetate 40 mg
Drug: glatiramer acetate 40 mg
glatiramer acetate 40 mg

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202982

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

No publications provided

Responsible Party: J. Michael Nicholas, Ph.D., Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00202982     History of Changes
Other Study ID Numbers: 9006
Study First Received: September 12, 2005
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 31, 2014