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

Multiple Sclerosis Clinical Trial

Official title:

Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937157
• Other study ID #: BNAC/GA/01
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: February 2021
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-ß, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Jacobs Neurological Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.		Change from baseline at 180 days and change from baseline at 360 days