Working… Menu

Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00937157
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : December 9, 2014
Last Update Posted : December 9, 2014
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Copaxone Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Drug: Copaxone
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

Primary Outcome Measures :
  1. A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. [ Time Frame: 0-180 days and 0-360 days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00937157

Layout table for location information
United States, New York
Jacobs Neurological Institute
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo
Teva Neuroscience, Inc.
Layout table for investigator information
Principal Investigator: Robert Zivadinov, MD, PhD University at Buffalo

Layout table for additonal information
Responsible Party: Robert Zivadinov, MD, PhD, Professor of Neurology, University at Buffalo Identifier: NCT00937157     History of Changes
Other Study ID Numbers: BNAC/GA/01
First Posted: July 10, 2009    Key Record Dates
Results First Posted: December 9, 2014
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:
Multiple Sclerosis
Glatiramer Acetate
Gd enhancing lesions
1.5T protocol
3T protocol
Magnetization transfer imaging (MTI)
Lesion activity analysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Glatiramer Acetate
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents