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The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F1 Glatiramer acetate 20mg/1.0ml | Active Comparator |
| |
| F2 Glatiramer acetate 20mg/0.5ml | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer Acetate | Drug | Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported Pain Associated Immediately After Each Injection | 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. | 5 weeks of injections |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Pain Within 5 Mins After Injection | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Smith, MD | Teva Neuroscience, Inc. | Study Director |
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| Label | URL |
|---|---|
| Visual Analog Scale definition | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | F1 Glatiramer Acetate 20mg/1.0ml | |
| FG001 | F2 Glatiramer Acetate 20mg/0.5ml |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7-Day Run-in Treatment Period |
| |||||||||||||
| 1st 14-day Treatment Period |
| |||||||||||||
| Crossover to 2nd 14-day Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F1 Glatiramer Acetate (GA) 20mg/1.0ml | |
| BG001 | F2 Glatiramer Acetate 20mg/0.5ml | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subject-reported Pain Associated Immediately After Each Injection | 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. | Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent. | Posted | Mean | Standard Deviation | Scores on a scale | 5 weeks of injections |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | F1 Glatiramer Acetate (GA) 20mg/1.0ml |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Smith, MD, VP, Medical Affairs | Teva Neuroscience, Inc. | 816-508-5000 | tom.smith@tevapharm.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Experimental Glatiramer Acetate | Drug | GA 20 mg/0.5 mL |
|
|
| 5 weeks of injections |
| NOT COMPLETED |
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| NOT COMPLETED |
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Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Degree of Pain Within 5 Mins After Injection | 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. | Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent. | Posted | Mean | Standard Deviation | Scores on a scale | 5 weeks of injections |
|
|
|
| 0 |
| 147 |
| 0 |
| 147 |
| EG001 | F2 Glatiramer Acetate 20mg/0.5ml | 0 | 147 | 0 | 147 |
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.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |