- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937157
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study
This study will:
Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.
- Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.
- Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.
This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- Jacobs Neurological Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with clinically definite MS according to the McDonald criteria
- Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
- Age 18-65
- Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of >9 T2 lesions in addition to 1 Gd lesion)
- Have EDSS scores less than or equal to 5.5
- Have disease duration of 3 months to 30 years
- None of the exclusion criteria
Exclusion Criteria:
- Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
|
12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc).
Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v.
daily for three days.
Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v.
daily for three days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
Time Frame: Change from baseline at 180 days and change from baseline at 360 days
|
Change from baseline at 180 days and change from baseline at 360 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Glatiramer Acetate
- (T,G)-A-L
Other Study ID Numbers
- BNAC/GA/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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