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Safety of New Formulation of Glatiramer Acetate (Song)

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ClinicalTrials.gov Identifier: NCT00947752
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : June 9, 2011
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: Glatiramer Acetate
Drug: Experimental Glatiramer Acetate
Enrollment 147
Recruitment Details Subjects were randomly assigned in a 1:1 assignment ratio to one of two drug sequences. Subjects were to manually inject GA (F1 or F2) once daily for 14 days then cross-over to the other formulation for another 14 days of treatment, including a 7-day run-in period on F1 treatment for all participants to assess daily diary compliance.
Pre-assignment Details To ensure the standardization, all study sites were instructed to train subjects to complete the daily diary, with special attention to the Visual Analog Scale (VAS) used to measure pain.
Arm/Group Title F1 Glatiramer Acetate 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: 7-Day Run-in Treatment Period
Started 147 [1] 0
Completed 147 0
Not Completed 0 0
[1]
All subjects started with a daily does of F1 for 7 days
Period Title: 1st 14-day Treatment Period
Started 76 71
Completed 76 71
Not Completed 0 0
Period Title: Crossover to 2nd 14-day Treatment Period
Started 71 76
Completed 71 76
Not Completed 0 0
Arm/Group Title F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 76 71 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 71 participants 147 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
  96.1%
71
 100.0%
144
  98.0%
>=65 years
3
   3.9%
0
   0.0%
3
   2.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 71 participants 147 participants
45.1  (10.64) 46.9  (9.64) 46.0  (10.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 71 participants 147 participants
Female
61
  80.3%
58
  81.7%
119
  81.0%
Male
15
  19.7%
13
  18.3%
28
  19.0%
1.Primary Outcome
Title Subject-reported Pain Associated Immediately After Each Injection
Hide Description A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.
Time Frame 5 weeks of injections
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.
Arm/Group Title F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
11.89  (14.325) 8.64  (10.825)
2.Secondary Outcome
Title Degree of Pain Within 5 Mins After Injection
Hide Description A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.
Time Frame 5 weeks of injections
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.
Arm/Group Title F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
17.19  (18.583) 11.85  (14.112)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Affected / at Risk (%) Affected / at Risk (%)
Total   0/147 (0.00%)   0/147 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
F1 Glatiramer Acetate (GA) 20mg/1.0ml F2 Glatiramer Acetate 20mg/0.5ml
Affected / at Risk (%) Affected / at Risk (%)
Total   0/147 (0.00%)   0/147 (0.00%) 
Blinding in this study was not possible due to the subjects' ability to detect difference in the volume of each formulation. The lack of blinding was a known limitation.
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Smith, MD, VP, Medical Affairs
Organization: Teva Neuroscience, Inc.
Phone: 816-508-5000
EMail: tom.smith@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00947752     History of Changes
Other Study ID Numbers: PM033
First Submitted: July 25, 2009
First Posted: July 28, 2009
Results First Submitted: September 28, 2010
Results First Posted: June 9, 2011
Last Update Posted: March 14, 2017