Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:12/16/2018
Start Date:March 26, 1994
End Date:February 28, 2018

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Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone®

Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple
Sclerosis status.


Inclusion Criteria:

- Patients must have participated (been randomized) in the Copaxone Double-Blind placebo
controlled study (Protocol 01-9001).

- Gender: Patients may be male or female. Women of childbearing potential must practice
an acceptable method of birth control.

- Patients must sign an approved informed consent prior to initiating the study.

- Patients must be psychologically and physically stable to participate in the trial as
judged by the investigator.

Exclusion Criteria:

- Pregnancy or lactation.

- Medical or psychiatric conditions that affect the patient's ability to give informed
consent or complete the study.

- Inability to self-administer subcutaneous medication or lack of another responsible
individual to administer the study preparation daily.

- Use of Interferons, experimental MS therapies, or previous immunosuppressive therapy
with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or
total lymphoid irradiation within 30 days of study entry.
We found this trial at
10
sites
Los Angeles, California
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Los Angeles, CA
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Albuquerque, New Mexico 87102
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Albuquerque, NM
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Baltimore, Maryland
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Baltimore, MD
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Detroit, Michigan
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Detroit, MI
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Houston, Texas 77054
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Houston, TX
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Madison, Wisconsin
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Madison, WI
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New Haven, Connecticut
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New Haven, CT
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Rochester, New York
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Rochester, NY
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Salt Lake City, Utah
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Salt Lake City, UT
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