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| Name | Class |
|---|---|
| Teva Neuroscience, Inc. | INDUSTRY |
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This study will:
Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Zivadinov, MD, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobs Neurological Institute | Buffalo | New York | 14203 | United States |
All enrolled patients had to meet all inclusion criteria and no exclusion criteria. Patients were to be 18-65 years of age, have a disease duration of 3months to 20 years, be diagnosed with RRMS according to McDonald criteria, one enhancing lesion 30 days prior to screening and an EDSS score equal to or below 5.5.
Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.
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| ID | Title | Description |
|---|---|---|
| FG000 | RRMS Patients With >=1 GdE Lesion or Acute Relapse | Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse. Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Diagnosed With Multiple Sclerosis Who Have the Presen | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. | Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used. | Posted | Mean | Standard Deviation | GAD lesions (number of) | Change from baseline at 180 days and change from baseline at 360 days | GAD lesions | GAD lesions |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RRMS Patients With >=1 GdE Lesion or Acute Relapse | Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse. Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Zivadinov, MD, PhD | Buffalo Neuroimaging Analysis Center | 716-859-7040 | rzivadinov@bnac.net |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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| GAD lesions |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |