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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    RRMS Patients With >=1 GdE Lesion or Acute Relapse
STARTED   12 
COMPLETED   8 
NOT COMPLETED   4 
Pregnancy                1 
Lost to Follow-up                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Patients Diagnosed With Multiple Sclerosis Who Have the Presen 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (7.823) 
Gender 
[Units: Participants]
 
Female   9 
Male   3 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.   [ Time Frame: 0-180 days and 0-360 days ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: rzivadinov@bnac.net



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