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

This study has been completed.
Sponsor:
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier:
NCT00937157
First received: July 9, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Multiple Sclerosis
Drug: Copaxone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • A decrease in the cumulative number of Gd enhancing lesions using a 3T protocol. [ Time Frame: day 0, 3, 6, 9, & 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2007
Study Completion Date: April 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937157

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

No publications provided

Responsible Party: Robert Zivadinov, MD, PhD, Professor of Neurology, University at Buffalo
ClinicalTrials.gov Identifier: NCT00937157     History of Changes
Other Study ID Numbers: BNAC/GA/01
Study First Received: July 9, 2009
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014