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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:
ClinicalTrials.gov Identifier:
NCT01578785
First Posted: April 17, 2012
Last Update Posted: April 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
Results First Submitted: February 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
Interventions: Drug: Glatiramer Acetate
Drug: Placebo

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



Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01578785     History of Changes
Other Study ID Numbers: GA-MS-302
2011-005550-57 ( EudraCT Number )
First Submitted: March 13, 2012
First Posted: April 17, 2012
Results First Submitted: February 19, 2014
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014