Back to resultsComparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Copaxone
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Inflammation, Multiple Sclerosis, Glatiramer Acetate, Gd enhancing lesions, 1.5T protocol, 3T protocol, Magnetization transfer imaging (MTI), Lesion activity analysis, Copaxone
Eligibility Criteria
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.)
Sites / Locations
- Jacobs Neurological Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Outcomes
Primary Outcome Measures
A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT00937157
First Posted
July 9, 2009
Last Updated
February 25, 2021
Sponsor
University at Buffalo
Collaborators
Teva Neuroscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00937157
Brief Title
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Teva Neuroscience, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Inflammation, Multiple Sclerosis, Glatiramer Acetate, Gd enhancing lesions, 1.5T protocol, 3T protocol, Magnetization transfer imaging (MTI), Lesion activity analysis, Copaxone
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Intervention Type
Drug
Intervention Name(s)
Copaxone
Other Intervention Name(s)
Glatiramer acetate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Zivadinov, MD, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobs Neurological Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
We'll reach out to this number within 24 hrs