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

• ClinicalTrials.gov Identifier: NCT00937157
• Recruitment Status: Completed
• First Posted: July 10, 2009
• Results First Posted: December 9, 2014
• Last Update Posted: March 19, 2021
• Sponsor: University at Buffalo
• Collaborator: Teva Neuroscience, Inc.
• Information provided by (Responsible Party): Robert Zivadinov, MD, PhD, University at Buffalo

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• 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

Arms and Interventions

Arm

Intervention/treatment

1; 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

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.)

Contacts and Locations

Locations

United States, New York

Jacobs Neurological Institute

Buffalo, New York, United States, 14203

Sponsors and Collaborators

University at Buffalo

Teva Neuroscience, Inc.

Investigators

• Principal Investigator: Robert Zivadinov, MD, PhD; University at Buffalo

More Information

• Responsible Party: Robert Zivadinov, MD, PhD, Professor of Neurology, University at Buffalo
• ClinicalTrials.gov Identifier: NCT00937157
• Other Study ID Numbers: BNAC/GA/01
• First Posted: July 10, 2009
• Results First Posted: December 9, 2014
• Last Update Posted: March 19, 2021
• Last Verified: February 2021

Keywords provided by Robert Zivadinov, MD, PhD, University at Buffalo:

Inflammation; Multiple Sclerosis; Glatiramer Acetate; Gd enhancing lesions; 1.5T protocol; 3T protocol; Magnetization transfer imaging (MTI); Lesion activity analysis; Copaxone

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Glatiramer Acetate; (T,G)-A-L; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents; Antirheumatic Agents