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

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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Multiple Sclerosis
Intervention Drug: Copaxone
Enrollment 12
Recruitment Details Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.
Pre-assignment Details 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.
Arm/Group Title RRMS Patients With >=1 GdE Lesion or Acute Relapse
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 12
Completed 8
Not Completed 4
Reason Not Completed
Pregnancy             1
Lost to Follow-up             3
Arm/Group Title Patients Diagnosed With Multiple Sclerosis Who Have the Presen
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
43  (7.823)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
9
  75.0%
Male
3
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
Hide Description [Not Specified]
Time Frame 0-180 days and 0-360 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.
Arm/Group Title Patients Diagnosed With Multiple Sclerosis Who Have the Presen
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Cumulative GAD lesions (number of)
3.6  (4.2)
2.Secondary Outcome
Title To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols.
Hide Description [Not Specified]
Time Frame day 0, 3, 6, 9 & 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RRMS Patients With >=1 GdE Lesion or Acute Relapse
Hide Arm/Group Description

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.

All-Cause Mortality
RRMS Patients With >=1 GdE Lesion or Acute Relapse
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RRMS Patients With >=1 GdE Lesion or Acute Relapse
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RRMS Patients With >=1 GdE Lesion or Acute Relapse
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert Zivadinov, MD, PhD
Organization: Buffalo Neuroimaging Analysis Center
Phone: 716-859-7040
Responsible Party: Robert Zivadinov, MD, PhD, University at Buffalo
ClinicalTrials.gov Identifier: NCT00937157     History of Changes
Other Study ID Numbers: BNAC/GA/01
First Submitted: July 9, 2009
First Posted: July 10, 2009
Results First Submitted: December 2, 2014
Results First Posted: December 9, 2014
Last Update Posted: December 9, 2014