An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (GLOW)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01578785
First received: March 13, 2012
Last updated: February 19, 2014
Last verified: February 2014
Results First Received: February 19, 2014  
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
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two hundred seventy-four patients were screened and 178 randomized into the study in a 1:2 treatment arm ratio.

Reporting Groups
  Description
Placebo Placebo solution in prefilled syringe for subcutaneous injection once daily.
GA 20 MG/0.5 ML Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.

Participant Flow:   Overall Study
    Placebo     GA 20 MG/0.5 ML  
STARTED     59     119  
COMPLETED     0     0  
NOT COMPLETED     59     119  
Withdrawal by Subject                 0                 1  
Study terminated by sponsor                 59                 118  



  Baseline Characteristics
  Hide 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
Placebo Placebo solution in prefilled syringe for subcutaneous injection once daily.
GA 20 mg/0.5 ml Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Total Total of all reporting groups

Baseline Measures
    Placebo     GA 20 mg/0.5 ml     Total  
Number of Participants  
[units: participants]
  59     119     178  
Age  
[units: years]
Mean ± Standard Deviation
     
AgeContinuous     37.7  ± 9.13     38.9  ± 8.36     38.5  ± 8.62  
Gender  
[units: participants]
     
Female     45     87     132  
Male     14     32     46  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     59     119     178  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     58     118     176  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Bulgaria     7     22     29  
Bosnia and Herzegovina     6     11     17  
Belarus     4     4     8  
Estonia     0     1     1  
Georgia     6     8     14  
Croatia     7     18     25  
Poland     19     35     54  
Romania     9     19     28  
USA     1     1     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Annualized Relapse Rate During the Placebo Controlled Period   [ Time Frame: Day 1 up to Month 12 ]

2.  Secondary:   The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)   [ Time Frame: Day 1 up to Month 12 ]

3.  Secondary:   The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)   [ Time Frame: Day 1 up to Month 12 ]

4.  Secondary:   Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume   [ Time Frame: Day 1 up to Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


No publications provided


Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01578785     History of Changes
Other Study ID Numbers: GA-MS-302, 2011-005550-57
Study First Received: March 13, 2012
Results First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration