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Trial Outcomes & Findings for Safety of New Formulation of Glatiramer Acetate (NCT NCT00947752)

NCT ID: NCT00947752

Last Updated: 2017-03-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

147 participants

Primary outcome timeframe

5 weeks of injections

Results posted on

2017-03-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
F1 Glatiramer Acetate 20mg/1.0ml
F2 Glatiramer Acetate 20mg/0.5ml
7-Day Run-in Treatment Period
STARTED
147
0
7-Day Run-in Treatment Period
COMPLETED
147
0
7-Day Run-in Treatment Period
NOT COMPLETED
0
0
1st 14-day Treatment Period
STARTED
76
71
1st 14-day Treatment Period
COMPLETED
76
71
1st 14-day Treatment Period
NOT COMPLETED
0
0
Crossover to 2nd 14-day Treatment Period
STARTED
71
76
Crossover to 2nd 14-day Treatment Period
COMPLETED
71
76
Crossover to 2nd 14-day Treatment Period
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of New Formulation of Glatiramer Acetate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
F1 Glatiramer Acetate (GA) 20mg/1.0ml
n=76 Participants
F2 Glatiramer Acetate 20mg/0.5ml
n=71 Participants
Total
n=147 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
73 Participants
n=5 Participants
71 Participants
n=7 Participants
144 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
Age, Continuous
45.1 years
STANDARD_DEVIATION 10.64 • n=5 Participants
46.9 years
STANDARD_DEVIATION 9.64 • n=7 Participants
46.0 years
STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male
Female
61 Participants
n=5 Participants
58 Participants
n=7 Participants
119 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
13 Participants
n=7 Participants
28 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks of injections

Population: Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.

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.

Outcome measures

Outcome measures
Measure
F2 Glatiramer Acetate 20mg/0.5ml
n=144 Participants
F1 Glatiramer Acetate (GA) 20mg/1.0ml
n=144 Participants
Subject-reported Pain Associated Immediately After Each Injection
8.64 Scores on a scale
Standard Deviation 10.825
11.89 Scores on a scale
Standard Deviation 14.325

SECONDARY outcome

Timeframe: 5 weeks of injections

Population: Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.

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.

Outcome measures

Outcome measures
Measure
F2 Glatiramer Acetate 20mg/0.5ml
n=144 Participants
F1 Glatiramer Acetate (GA) 20mg/1.0ml
n=144 Participants
Degree of Pain Within 5 Mins After Injection
11.85 Scores on a scale
Standard Deviation 14.112
17.19 Scores on a scale
Standard Deviation 18.583

Adverse Events

F1 Glatiramer Acetate (GA) 20mg/1.0ml

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

F2 Glatiramer Acetate 20mg/0.5ml

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Smith, MD, VP, Medical Affairs

Teva Neuroscience, Inc.

Phone: 816-508-5000

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER