Trial Outcomes & Findings for Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia (NCT NCT04871451)
NCT ID: NCT04871451
Last Updated: 2024-08-22
Results Overview
The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose.
COMPLETED
PHASE2
51 participants
Up to 52 weeks
2024-08-22
Participant Flow
Participants who completed ABP-19000 study had the option to roll over to this ABP-19002 study at the same site they were previously enrolled.
Of the 57 who completed ABP-19000 study, 51 participants were dosed and 51were included in the modified full analysis set (mFAS) for the efficacy analysis.
Participant milestones
| Measure |
ABP-450 - 150U
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
17
|
9
|
|
Overall Study
COMPLETED
|
18
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
Baseline characteristics by cohort
| Measure |
ABP-450 - 150U
n=25 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=17 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=9 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
17 participants
n=7 Participants
|
9 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Weight (kg)
|
78.71 kg
STANDARD_DEVIATION 15.18 • n=5 Participants
|
73.6 kg
STANDARD_DEVIATION 15.69 • n=7 Participants
|
98.66 kg
STANDARD_DEVIATION 24.84 • n=5 Participants
|
79.86 kg
STANDARD_DEVIATION 18.65 • n=4 Participants
|
|
BMI
|
28.02 kg/m2
STANDARD_DEVIATION 4.69 • n=5 Participants
|
27.22 kg/m2
STANDARD_DEVIATION 4.96 • n=7 Participants
|
31.69 kg/m2
STANDARD_DEVIATION 6.18 • n=5 Participants
|
28.28 kg/m2
STANDARD_DEVIATION 5.13 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The safety analysis set consisted of all patients who received at least 1 dose of ABP-450. The safety analysis set was used to analyze all safety data.
The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose.
Outcome measures
| Measure |
ABP-450 - 150U
n=25 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=17 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=9 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Number of Participants With Treatment-related Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale is used to assess the severity of cervical Dystonia. The TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It comprises 3 subscales, which are summated to get the total score: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Baseline
|
41.58 units on a scale
Standard Deviation 9.369
|
42.87 units on a scale
Standard Deviation 6.631
|
45.63 units on a scale
Standard Deviation 5.483
|
|
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Cycle 1, Week 4
|
27.54 units on a scale
Standard Deviation 15.873
|
28.47 units on a scale
Standard Deviation 12.743
|
34.17 units on a scale
Standard Deviation 6.166
|
|
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Cycle 2, Week 4
|
31.17 units on a scale
Standard Deviation 15.205
|
24.0 units on a scale
Standard Deviation 12.808
|
23.71 units on a scale
Standard Deviation 10.917
|
|
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Cycle 3, Week 4
|
28.19 units on a scale
Standard Deviation 14.179
|
24.17 units on a scale
Standard Deviation 12.302
|
24.82 units on a scale
Standard Deviation 9.558
|
|
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Cycle 4, Week 4
|
31.45 units on a scale
Standard Deviation 15.666
|
28.6 units on a scale
Standard Deviation 11.967
|
27.75 units on a scale
Standard Deviation 9.601
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Severity subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of torticollis in cervical dystonia. The severity subscale has a minimum score of 0 and maximum score of 35, where higher scores represent worse outcomes.
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Baseline
|
18.8 units on a scale
Standard Deviation 3.92
|
19.6 units on a scale
Standard Deviation 2.71
|
22.3 units on a scale
Standard Deviation 2.22
|
|
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 1, Week 4
|
12.6 units on a scale
Standard Deviation 6.38
|
14.0 units on a scale
Standard Deviation 4.97
|
19.3 units on a scale
Standard Deviation 1.53
|
|
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 2, Week 4
|
15.3 units on a scale
Standard Deviation 5.56
|
11.0 units on a scale
Standard Deviation 6.55
|
14.4 units on a scale
Standard Deviation 5.71
|
|
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 3, Week 4
|
12.1 units on a scale
Standard Deviation 5.59
|
11.1 units on a scale
Standard Deviation 6.44
|
13.6 units on a scale
Standard Deviation 5.97
|
|
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 4, Week 4
|
12.6 units on a scale
Standard Deviation 6.39
|
14.8 units on a scale
Standard Deviation 4.96
|
15.8 units on a scale
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of disability in cervical dystonia. The disability subscale has a minimum score of 0 and maximum score of 30, where higher scores represent worse outcomes.
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Baseline
|
11.2 units on a scale
Standard Deviation 4.78
|
11.9 units on a scale
Standard Deviation 4.17
|
12.5 units on a scale
Standard Deviation 2.89
|
|
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 1, Week 4
|
6.9 units on a scale
Standard Deviation 6.75
|
7.8 units on a scale
Standard Deviation 5.29
|
9.0 units on a scale
Standard Deviation 2.65
|
|
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 2, Week 4
|
8.8 units on a scale
Standard Deviation 6.68
|
6.7 units on a scale
Standard Deviation 5.43
|
5.0 units on a scale
Standard Deviation 4.12
|
|
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 3, Week 4
|
9.1 units on a scale
Standard Deviation 5.62
|
6.7 units on a scale
Standard Deviation 4.58
|
5.4 units on a scale
Standard Deviation 2.94
|
|
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 4, Week 4
|
9.6 units on a scale
Standard Deviation 5.81
|
6.8 units on a scale
Standard Deviation 5.71
|
6.2 units on a scale
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Pain subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of pain in cervical dystonia. The pain subscale has a minimum score of 0 and maximum score of 20, where higher scores represent worse outcomes.
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Baseline
|
11.576 units on a scale
Standard Deviation 3.0697
|
11.342 units on a scale
Standard Deviation 3.0824
|
10.875 units on a scale
Standard Deviation 2.7195
|
|
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 1, Week 4
|
8.060 units on a scale
Standard Deviation 5.1386
|
6.639 units on a scale
Standard Deviation 5.1071
|
5.833 units on a scale
Standard Deviation 4.7719
|
|
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 2, Week 4
|
7.167 units on a scale
Standard Deviation 5.3940
|
6.333 units on a scale
Standard Deviation 3.8441
|
4.286 units on a scale
Standard Deviation 2.9595
|
|
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 3, Week 4
|
6.938 units on a scale
Standard Deviation 4.6209
|
6.348 units on a scale
Standard Deviation 4.4573
|
5.821 units on a scale
Standard Deviation 4.3702
|
|
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Cycle 4, Week 4
|
9.250 units on a scale
Standard Deviation 4.5104
|
6.904 units on a scale
Standard Deviation 3.9112
|
5.750 units on a scale
Standard Deviation 2.7884
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Patient Global Impression of Change (PGI-C) enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse. The mean change in the subject's assessment of the change in clinical status since the start of treatment measured by the Patients' Global Impression of Change (PGI-C) Scale was assessed by Treatment Group at Week 4.
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in Patient Global Impression of Change (PGI-C)
Baseline
|
3.8 units on a scale
Standard Deviation 1.68
|
4.1 units on a scale
Standard Deviation 1.35
|
3.8 units on a scale
Standard Deviation 2.36
|
|
Mean Change in Patient Global Impression of Change (PGI-C)
Cycle 1, Week 4
|
2.1 units on a scale
Standard Deviation 1.14
|
2.2 units on a scale
Standard Deviation 1.17
|
1.7 units on a scale
Standard Deviation 0.58
|
|
Mean Change in Patient Global Impression of Change (PGI-C)
Cycle 2, Week 4
|
2.2 units on a scale
Standard Deviation 1.53
|
2.4 units on a scale
Standard Deviation 1.63
|
1.6 units on a scale
Standard Deviation 0.79
|
|
Mean Change in Patient Global Impression of Change (PGI-C)
Cycle 3, Week 4
|
1.8 units on a scale
Standard Deviation 0.89
|
2.4 units on a scale
Standard Deviation 1.47
|
1.9 units on a scale
Standard Deviation 0.69
|
|
Mean Change in Patient Global Impression of Change (PGI-C)
Cycle 4, Week 4
|
1.8 units on a scale
Standard Deviation 0.84
|
1.4 units on a scale
Standard Deviation 0.77
|
2.0 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Four weeks after the dose of each cycle (4 cycles)Population: Included all patients in the safety analysis set, but excluded patients who had significant changes to their "stable" background medication, received a dose outside the dose range or received alternative or prohibited medications, or did not receive at least 1 treatment of ABP-450 during the OLE study. The number of participants in each treatment cycle could change due to dose multiplication, however for the outcome measure data table the numbers reflect cycle 1.
The Clinical Global Impression of Change (CGI-C) enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse. The mean change from Baseline in the Clinical Global Impression of Change (CGI-C) Score was assessed by Treatment Group at Week 4.
Outcome measures
| Measure |
ABP-450 - 150U
n=23 Participants
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=19 Participants
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=4 Participants
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Mean Change in Clinical Global Impression of Change (CGI-C)
Baseline
|
3.4 units on a scale
Standard Deviation 1.44
|
3.7 units on a scale
Standard Deviation 1.37
|
3.8 units on a scale
Standard Deviation 1.71
|
|
Mean Change in Clinical Global Impression of Change (CGI-C)
Cycle 1, Week 4
|
2.1 units on a scale
Standard Deviation 0.94
|
1.9 units on a scale
Standard Deviation 0.94
|
1.7 units on a scale
Standard Deviation 0.58
|
|
Mean Change in Clinical Global Impression of Change (CGI-C)
Cycle 2, Week 4
|
2.5 units on a scale
Standard Deviation 1.24
|
2.0 units on a scale
Standard Deviation 1.52
|
1.7 units on a scale
Standard Deviation 0.76
|
|
Mean Change in Clinical Global Impression of Change (CGI-C)
Cycle 3, Week 4
|
2.1 units on a scale
Standard Deviation 0.83
|
2.2 units on a scale
Standard Deviation 1.15
|
1.9 units on a scale
Standard Deviation 0.69
|
|
Mean Change in Clinical Global Impression of Change (CGI-C)
Cycle 4, Week 4
|
2.0 units on a scale
Standard Deviation 0.71
|
1.8 units on a scale
Standard Deviation 0.60
|
1.8 units on a scale
Standard Deviation 0.75
|
Adverse Events
ABP-450 - 150U
ABP-450 - 250U
ABP-450 - 350U
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABP-450 - 150U
n=25 participants at risk
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 250U
n=17 participants at risk
ABP-450 Medium Dose - Intramuscular injections into affected neck muscles.
|
ABP-450 - 350U
n=9 participants at risk
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
24.0%
6/25 • 52 Weeks
|
23.5%
4/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Infections and infestations
Upper Respiratory tract infection
|
8.0%
2/25 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/25 • 52 Weeks
|
5.9%
1/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/25 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.0%
2/25 • 52 Weeks
|
17.6%
3/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • 52 Weeks
|
5.9%
1/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/25 • 52 Weeks
|
5.9%
1/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • 52 Weeks
|
5.9%
1/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Gastrointestinal disorders
Dysphagia
|
12.0%
3/25 • 52 Weeks
|
17.6%
3/17 • 52 Weeks
|
22.2%
2/9 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/25 • 52 Weeks
|
5.9%
1/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/25 • 52 Weeks
|
11.8%
2/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
|
General disorders
Injection site pain
|
12.0%
3/25 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
0.00%
0/9 • 52 Weeks
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
22.2%
2/9 • 52 Weeks
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • 52 Weeks
|
0.00%
0/17 • 52 Weeks
|
11.1%
1/9 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place