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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 March 2013 |
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Main ID: |
NCT00203021 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.
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Scientific title:
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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® |
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Date of first enrolment:
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July 1994 |
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Target sample size:
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208 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00203021 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Johnson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland |
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Key inclusion & exclusion criteria
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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 meet the criteria of clinically definite MS as defined by Poser.5
- The patient's signs and symptoms cannot be better explained by another disease
process.
- 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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Glatiramer acetate
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Primary Outcome(s)
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EDSS for efficacy every 6 months and adverse events for safety every 3 months.
[Time Frame: 17 years]
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Secondary Outcome(s)
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MRI data & Quality Of Life data periodically during study
[Time Frame: 17 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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