Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
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|ClinicalTrials.gov Identifier: NCT00937157|
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : December 9, 2014
Last Update Posted : December 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Copaxone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||April 2011|
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 Name: Glatiramer acetate
- A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. [ Time Frame: 0-180 days and 0-360 days ]
- To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols. [ Time Frame: day 0, 3, 6, 9 & 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937157
|United States, New York|
|Jacobs Neurological Institute|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Robert Zivadinov, MD, PhD||University at Buffalo|