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  
Number of Participants  
[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


No publications provided


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