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Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00337779
First received: June 14, 2006
Last updated: October 6, 2011
Last verified: October 2011
Results First Received: January 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Glatiramer Acetate (GA) 40 mg
Drug: glatiramer acetate 20 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted according to laws, regulations and administrative provisions related to implementation of Good Clinical Practice as applicable by legislation directives and Standard Operating Procedures. Subjects entered study after being informed and given time to contemplate consent. Enrollment began September 2006 and completed May 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects underwent evaluations including vital signs (blood pressure, pulse, and temperature,) adverse events, concomitant medications and neurological evaluation prior to study entry.

Reporting Groups
  Description
Glatiramer Acetate 20 mg No text entered.
Glatiramer Acetate 40 mg No text entered.

Participant Flow:   Overall Study
    Glatiramer Acetate 20 mg   Glatiramer Acetate 40 mg
STARTED   586   569 
COMPLETED   534   490 
NOT COMPLETED   52   79 
Withdrawal by Subject                10                12 
Sponsor decision                1                1 
Physician Decision                3                6 
Protocol Violation                1                1 
Lost to Follow-up                6                5 
Adverse Event                28                51 
Pregnancy                3                2 
Death                0                1 



  Baseline Characteristics
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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
Glatiramer Acetate 20 mg No text entered.
Glatiramer Acetate 40 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   Glatiramer Acetate 20 mg   Glatiramer Acetate 40 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 586   569   1155 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   586   569   1155 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.3  (9.0)   36.3  (9.0)   36.3  (9.0) 
Gender 
[Units: Participants]
     
Female   421   407   828 
Male   165   162   327 
Region of Enrollment 
[Units: Participants]
     
Argentina   14   14   28 
Belgium   0   1   1 
Canada   15   13   28 
Czech Republic   33   34   67 
Estonia   11   12   23 
Finland   9   7   16 
France   10   11   21 
Germany   50   48   98 
Hungary   27   27   54 
Israel   14   14   28 
Italy   47   43   90 
Latvia   14   14   28 
Lithuania   14   14   28 
Netherlands   7   6   13 
Poland   36   35   71 
Romania   29   28   57 
Russian Federation   87   88   175 
Spain   23   22   45 
United Kingdom   11   10   21 
United States   135   128   263 


  Outcome Measures
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1.  Primary:   The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).   [ Time Frame: 12 months ]

2.  Secondary:   The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.   [ Time Frame: 12 months ]

3.  Secondary:   The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chen Duksin, MD
Organization: Teva Pharmaceutical Industries, Ltd.
phone: 972-9-863-4642
e-mail: chen.duksin@teva.co.il



Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00337779     History of Changes
Other Study ID Numbers: GA/9016 (FORTE)
Study First Received: June 14, 2006
Results First Received: January 18, 2010
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration