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

NCT00937157 | Completed Results

• 1 other identifier: BNAC/GA/01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

OTHER

Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.

Drug: Copaxone

Interventions

Copaxone DRUG

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.

Also known as: Glatiramer acetate

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University at Buffalo: lead
• Teva Neuroscience, Inc.: collaborator

Study Sites (1)

Jacobs Neurological Institute

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Inflammation

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Robert Zivadinov, MD, PhD
• Organization: Buffalo Neuroimaging Analysis Center

rzivadinov@bnac.net

716-859-7040

Study Officials

• Robert Zivadinov, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2011
• Last Updated: March 19, 2021
• Results First Posted: December 9, 2014

Record last verified: 2021-02

Locations

US (1)