Trial Outcomes & Findings for Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine (NCT NCT02037425)
NCT ID: NCT02037425
Last Updated: 2016-08-11
Results Overview
Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
Weeks 12, 24, and 36 Post Randomization
Results posted on
2016-08-11
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA
At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
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|---|---|
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Overall Study
STARTED
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44
|
|
Overall Study
Randomized to Treatment
|
32
|
|
Overall Study
COMPLETED
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18
|
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Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA
n=32 Participants
At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.56 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 12, 24, and 36 Post RandomizationPopulation: Subjects included in this outcome measure analysis include those completing treatment period 1 injection cycle and returning at visit 3.
Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
|
Subject Global Impression of Change
Week 12 Post Randomization
|
4.43 units on a scale
Standard Deviation 1.94
|
5.67 units on a scale
Standard Deviation 0.47
|
1.67 units on a scale
Standard Deviation 1.80
|
|
Subject Global Impression of Change
Week 24 Post Randomization
|
4.76 units on a scale
Standard Deviation 1.38
|
5.33 units on a scale
Standard Deviation 0.47
|
3.33 units on a scale
Standard Deviation 1.60
|
|
Subject Global Impression of Change
Week 36 Post Randomization
|
4.14 units on a scale
Standard Deviation 2.17
|
5.33 units on a scale
Standard Deviation 0.47
|
2.50 units on a scale
Standard Deviation 1.80
|
PRIMARY outcome
Timeframe: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 daysCompare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
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Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C
Treatment Period 1
|
62 percentage of responders
|
67 percentage of responders
|
0 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C
Treatment Period 2
|
62 percentage of responders
|
100 percentage of responders
|
50 percentage of responders
|
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Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C
Treatment Period 3
|
62 percentage of responders
|
100 percentage of responders
|
50 percentage of responders
|
SECONDARY outcome
Timeframe: From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 daysComparison of headache days per month over each injection cycle between Groups A, B, and C (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Subjects will remain in their assigned groups based on assessment at 12 weeks.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
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Headache Days
Baseline
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21.95 number of headache days
Standard Deviation 4.19
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22.33 number of headache days
Standard Deviation 2.36
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24.83 number of headache days
Standard Deviation 3.02
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Headache Days
Treatment Period 1
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44.76 number of headache days
Standard Deviation 19.80
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37.0 number of headache days
Standard Deviation 10.61
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64.83 number of headache days
Standard Deviation 11.71
|
|
Headache Days
Treatment Period 2
|
35.06 number of headache days
Standard Deviation 21.27
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29.33 number of headache days
Standard Deviation 12.66
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55 number of headache days
Standard Deviation 21.88
|
|
Headache Days
Treatment Period 3
|
31.43 number of headache days
Standard Deviation 22.0
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29.33 number of headache days
Standard Deviation 12.66
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65.67 number of headache days
Standard Deviation 22.43
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for MIDAS total scores (effect migraine headaches have on subjects daily function) measured at baseline and weeks 12, 24, and 36. Total score of disability ranges: * 0 to 5, MIDAS Grade I, Little or no disability * 6 to 10, MIDAS Grade II, Mild disability * 11 to 20, MIDAS Grade III, Moderate disability * 21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
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Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
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|---|---|---|---|
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Migraine Disability Assessment Scale (MIDAS)
Baseline
|
84.19 units on a scale
Standard Deviation 54.60
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115.67 units on a scale
Standard Deviation 55.26
|
74.33 units on a scale
Standard Deviation 56.78
|
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Migraine Disability Assessment Scale (MIDAS)
Week 12 Post Randomization
|
19.90 units on a scale
Standard Deviation 14.44
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25.67 units on a scale
Standard Deviation 11.12
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96.83 units on a scale
Standard Deviation 70.07
|
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Migraine Disability Assessment Scale (MIDAS)
Week 24 Post Randomization
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27.65 units on a scale
Standard Deviation 22.03
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28.00 units on a scale
Standard Deviation 5.89
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66.33 units on a scale
Standard Deviation 44.54
|
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Migraine Disability Assessment Scale (MIDAS)
Week 36 Post Randomization
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28.29 units on a scale
Standard Deviation 28.35
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30.33 units on a scale
Standard Deviation 15.80
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86.00 units on a scale
Standard Deviation 40.56
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for SRRS scores (impact of common stressors) measured at baseline and weeks 12, 24, and 36. Scores can range from 0 to an undetermined amount, as subjects are allowed to rate unlisted events according to their own sense of stress. A total lower than 150 suggests a low level of stress and a low probability of developing a stress-related disorder. Scores greater than 150 suggest higher levels of stress and higher probabilities of developing stress-related disorders.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
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Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
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|---|---|---|---|
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Social Readjustment Rating Scale (SRRS)
Baseline
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168.68 units on a scale
Standard Deviation 108.77
|
157.00 units on a scale
Standard Deviation 81.86
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199.50 units on a scale
Standard Deviation 161.30
|
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Social Readjustment Rating Scale (SRRS)
Week 12 Post Randomization
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131.76 units on a scale
Standard Deviation 115.98
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168.33 units on a scale
Standard Deviation 57.05
|
141.67 units on a scale
Standard Deviation 99.60
|
|
Social Readjustment Rating Scale (SRRS)
Week 24 Post Randomization
|
85.33 units on a scale
Standard Deviation 81.33
|
215.33 units on a scale
Standard Deviation 163.94
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122.50 units on a scale
Standard Deviation 138.08
|
|
Social Readjustment Rating Scale (SRRS)
Week 36 Post Randomization
|
81.81 units on a scale
Standard Deviation 93.02
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221.00 units on a scale
Standard Deviation 117.29
|
70.83 units on a scale
Standard Deviation 87.49
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SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for PGIC scores measured at weeks 12, 24, and 36. the PGIC scale scores range from 0-7 with 0 being Very Much Worse and 7 being Very Much Improved. A higher score indicates a greater impression of change.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
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Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
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|---|---|---|---|
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Physician Global Impression of Change (PGIC)
Week 36 Post Randomization
|
4.81 units on a scale
Standard Deviation 1.10
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5.00 units on a scale
Standard Deviation 0.82
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3.67 units on a scale
Standard Deviation 0.94
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Physician Global Impression of Change (PGIC)
Week 12 Post Randomization
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4.95 units on a scale
Standard Deviation 1.05
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5.33 units on a scale
Standard Deviation 0.47
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3.50 units on a scale
Standard Deviation 1.26
|
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Physician Global Impression of Change (PGIC)
Week 24 Post Randomization
|
5.00 units on a scale
Standard Deviation 1.02
|
5.33 units on a scale
Standard Deviation 0.47
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4.00 units on a scale
Standard Deviation 0.58
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36. A total score of 0-10 = these ups and downs are considered normal, 11-16 = mild mood disturbance,17-20 = borderline clinical depression, 21-30 = moderate depression, 31-40 = severe depression, over 40 = extreme depression
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
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Beck Depression Inventory II (BDI-II)
Baseline
|
11.62 units on a scale
Standard Deviation 10.27
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16.67 units on a scale
Standard Deviation 6.13
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11.83 units on a scale
Standard Deviation 6.41
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Beck Depression Inventory II (BDI-II)
Week 12 Post Randomization
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8.43 units on a scale
Standard Deviation 9.20
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11.00 units on a scale
Standard Deviation 3.27
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7.67 units on a scale
Standard Deviation 2.92
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Beck Depression Inventory II (BDI-II)
Week 24 Post Randomization
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7.48 units on a scale
Standard Deviation 9.10
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12.33 units on a scale
Standard Deviation 5.44
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7.00 units on a scale
Standard Deviation 4.97
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Beck Depression Inventory II (BDI-II)
Week 36 Post Randomization
|
9.00 units on a scale
Standard Deviation 9.19
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7.00 units on a scale
Standard Deviation 4.97
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7.00 units on a scale
Standard Deviation 4.04
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36. Scores range from 20-80, with 20 indicating lower levels of anxiety most generally, and 80 indicating higher levels of anxiety most generally.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
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|---|---|---|---|
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State-Trait Anxiety Inventory (STAI)
Week 24 Post Randomization
|
36.62 units on a scale
Standard Deviation 9.73
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38.00 units on a scale
Standard Deviation 11.43
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38.00 units on a scale
Standard Deviation 6.16
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|
State-Trait Anxiety Inventory (STAI)
Baseline
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38.76 units on a scale
Standard Deviation 17.97
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43.67 units on a scale
Standard Deviation 13.89
|
40.67 units on a scale
Standard Deviation 7.25
|
|
State-Trait Anxiety Inventory (STAI)
Week 12 Post Randomization
|
36.05 units on a scale
Standard Deviation 10.08
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40.00 units on a scale
Standard Deviation 6.53
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36.50 units on a scale
Standard Deviation 8.64
|
|
State-Trait Anxiety Inventory (STAI)
Week 36 Post Randomization
|
36.86 units on a scale
Standard Deviation 9.92
|
36.33 units on a scale
Standard Deviation 6.94
|
38.33 units on a scale
Standard Deviation 8.79
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SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 36 Post RandomizationComparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36 post-randomization. A single sleep quality question was asked indicating quality of sleep over the past four weeks. The scale ranged from 1-5, with 1 being very poor quality and 5 being very good quality of sleep.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
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Sleep Quality Question
Baseline
|
3.19 units on a scale
Standard Deviation 1.01
|
3.33 units on a scale
Standard Deviation 0.47
|
3.00 units on a scale
Standard Deviation 0.58
|
|
Sleep Quality Question
Week 12 Post Randomization
|
3.48 units on a scale
Standard Deviation 0.85
|
3.67 units on a scale
Standard Deviation 0.47
|
2.5 units on a scale
Standard Deviation 0.50
|
|
Sleep Quality Question
Week 24 Post Randomization
|
3.57 units on a scale
Standard Deviation 0.95
|
3.33 units on a scale
Standard Deviation 0.47
|
2.83 units on a scale
Standard Deviation 0.69
|
|
Sleep Quality Question
Week 36 Post Randomization
|
3.38 units on a scale
Standard Deviation 1.05
|
3.67 units on a scale
Standard Deviation 1.25
|
2.50 units on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 daysComparison of acute medication usage between Groups A, B, and C during baseline, Treatment Period 1, 2, and 3.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
|
Acute Medication Usage
Baseline
|
16.29 number of medications used
Standard Deviation 10.92
|
12.00 number of medications used
Standard Deviation 5.10
|
13.83 number of medications used
Standard Deviation 5.46
|
|
Acute Medication Usage
Treatment Period 1
|
36.53 number of medications used
Standard Deviation 24.26
|
20.67 number of medications used
Standard Deviation 9.03
|
36.00 number of medications used
Standard Deviation 19.72
|
|
Acute Medication Usage
Treatment Period 2
|
28.33 number of medications used
Standard Deviation 20.98
|
26.33 number of medications used
Standard Deviation 10.08
|
28.33 number of medications used
Standard Deviation 16.02
|
|
Acute Medication Usage
Treatment Period 3
|
25.71 number of medications used
Standard Deviation 18.77
|
9.67 number of medications used
Standard Deviation 6.60
|
28.00 number of medications used
Standard Deviation 16.39
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 36 Post RandomizationCompare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations as measured by the number of responders. A responder is defined as a 30% reduction from baseline in the number of headache days.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
|
Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles
Treatment Period 1
|
13 participants
|
2 participants
|
0 participants
|
|
Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles
Treatment Period 2
|
13 participants
|
3 participants
|
3 participants
|
|
Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles
Treatment Period 3
|
13 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Weeks 9, 10, 11, 12, 21, 22, 23, 24, 33, 34, 35, 36 Post RandomizationCompare duration of benefit of onabotulinumtoxinA response through 3 injection cycles as measured by headache days per week (including the last 4 weeks of every injection cycle). A percent of responders was calculated using a 30% reduction of the number of headache days compared to average number of headache per week during baseline.
Outcome measures
| Measure |
Group A
n=21 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=3 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=6 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 9 Post Randomization
|
57 percentage of responders
|
33 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 10 Post Randomization
|
57 percentage of responders
|
67 percentage of responders
|
17 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 11 Post Randomization
|
52 percentage of responders
|
67 percentage of responders
|
0 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 12 Post Randomization
|
38 percentage of responders
|
67 percentage of responders
|
17 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 21 Post Randomization
|
76 percentage of responders
|
67 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 22 Post Randomization
|
62 percentage of responders
|
67 percentage of responders
|
50 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 23 Post Randomization
|
57 percentage of responders
|
100 percentage of responders
|
50 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 24 Post Randomization
|
52 percentage of responders
|
67 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 33 Post Randomization
|
62 percentage of responders
|
67 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 34 Post Randomization
|
71 percentage of responders
|
100 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 35 Post Randomization
|
48 percentage of responders
|
100 percentage of responders
|
33 percentage of responders
|
|
Duration of onabotulinumtoxinA Over 3 Injection Cycles
Week 36 Post Randomization
|
48 percentage of responders
|
100 percentage of responders
|
17 percentage of responders
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline & Week 12 Post RandomizationPopulation: Only a subset of subjects (n = 14) completed this endpoint for the trial based on the protocol design.
Compare neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA in Groups A, B, C from baseline to 12 weeks post randomization. Neuronal regrowth change was scored on a 0-3 point scale with 0 being no change from baseline in regrowth and 3 being significant change from baseline.
Outcome measures
| Measure |
Group A
n=9 Participants
Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
|
Group B
n=2 Participants
Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
|
Group C
n=3 Participants
Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
|
|---|---|---|---|
|
Neuronal Regrowth
Beta Tublin
|
.61 units on a scale
Standard Deviation .66
|
0.0 units on a scale
Standard Deviation 0.0
|
1.17 units on a scale
Standard Deviation 1.02
|
|
Neuronal Regrowth
Calcitonin Gene-Related Peptide
|
1.06 units on a scale
Standard Deviation 1.01
|
0.0 units on a scale
Standard Deviation 0.0
|
1.0 units on a scale
Standard Deviation 1.41
|
|
Neuronal Regrowth
SNAP25 (Synaptosomal-Associated Protein)
|
1.22 units on a scale
Standard Deviation 1.03
|
0.5 units on a scale
Standard Deviation 0.5
|
0.67 units on a scale
Standard Deviation 0.47
|
Adverse Events
onabotulinumtoxinA
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA
n=44 participants at risk
At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
|
|---|---|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Nervous system disorders
Expressive Aphasia
|
2.3%
1/44 • Number of events 1 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Nervous system disorders
Unsteady Gait
|
2.3%
1/44 • Number of events 1 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous Abortion
|
2.3%
1/44 • Number of events 1 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
Other adverse events
| Measure |
onabotulinumtoxinA
n=44 participants at risk
At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.8%
3/44 • Number of events 3 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
9.1%
4/44 • Number of events 4 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Musculoskeletal and connective tissue disorders
Eyebrow Droop
|
6.8%
3/44 • Number of events 3 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Musculoskeletal and connective tissue disorders
Eyebrow Heaviness
|
4.5%
2/44 • Number of events 2 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.5%
2/44 • Number of events 3 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Infections and infestations
Sinus Infection
|
4.5%
2/44 • Number of events 2 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Infections and infestations
Strep Throat
|
9.1%
4/44 • Number of events 4 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Infections and infestations
Upper Respiratory Infection
|
6.8%
3/44 • Number of events 3 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
|
Metabolism and nutrition disorders
Weight Gain
|
9.1%
4/44 • Number of events 4 • From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days
|
Additional Information
Dr. Roger Cay, M.D.
Clinvest/A Division of Banyan Group Inc.
Phone: 417-883-7889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place