Trial Outcomes & Findings for BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence (NCT NCT03861936)
NCT ID: NCT03861936
Last Updated: 2021-04-28
Results Overview
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
COMPLETED
PHASE2
150 participants
Day 90
2021-04-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
53
|
49
|
|
Overall Study
COMPLETED
|
34
|
43
|
39
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
|
Overall Study
Reason not Specified
|
5
|
5
|
3
|
Baseline Characteristics
BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.11 • n=93 Participants
|
38.3 years
STANDARD_DEVIATION 10.50 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 10.60 • n=27 Participants
|
39.3 years
STANDARD_DEVIATION 11.05 • n=483 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
130 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
119 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
110 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment.
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
|
21.7 percentage of participants
Interval 9.8 to 33.7
|
90.6 percentage of participants
Interval 82.7 to 98.4
|
91.3 percentage of participants
Interval 83.2 to 99.4
|
PRIMARY outcome
Timeframe: First dose (Day 1) to the End of Study (Up to Day 180)Population: Safety Population consisted of all participants who received at least 1 injection of study intervention.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
12 Participants
|
18 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to the End of Study (Up to Day 180)Population: Safety Population consisted of all participants who received at least 1 injection of study intervention. Number analyzed is the number of participants with data available at the given time-point.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
Baseline
|
115.8 millimeters of mercury (mmHg)
Standard Deviation 13.52
|
118.6 millimeters of mercury (mmHg)
Standard Deviation 10.39
|
114.7 millimeters of mercury (mmHg)
Standard Deviation 13.64
|
|
Change From Baseline in Systolic Blood Pressure
Change from Baseline to End of Study
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 10.09
|
-1.2 millimeters of mercury (mmHg)
Standard Deviation 12.05
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 10.82
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to the End of Study (Up to Day 180)Population: Safety Population consisted of all participants who received at least 1 injection of study intervention. Number analyzed is the number of participants with data available at the given time-point.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
Baseline
|
76.8 mmHg
Standard Deviation 8.28
|
77.7 mmHg
Standard Deviation 8.63
|
76.6 mmHg
Standard Deviation 10.09
|
|
Change From Baseline in Diastolic Blood Pressure
Change from Baseline to End of Study
|
0.1 mmHg
Standard Deviation 6.72
|
-0.2 mmHg
Standard Deviation 8.07
|
0.8 mmHg
Standard Deviation 9.44
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to the End of Study (Up to Day 180)Population: Safety Population consisted of all participants who received at least 1 injection of study intervention. Number analyzed is the number of participants with data available at the given time-point.
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate
Baseline
|
15.5 breaths/minute
Standard Deviation 2.01
|
15.6 breaths/minute
Standard Deviation 2.14
|
15.2 breaths/minute
Standard Deviation 1.92
|
|
Change From Baseline in Respiratory Rate
Change from Baseline to End of Study
|
0.1 breaths/minute
Standard Deviation 1.75
|
0.1 breaths/minute
Standard Deviation 1.85
|
0.1 breaths/minute
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to the End of Study (Up to Day 180) ]Population: Safety Population consisted of all participants who received at least 1 injection of study intervention. Number analyzed is the number of participants with data available at the given time-point.
Pulse rate measures the number of times your heart beats per minute.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
Baseline
|
76.9 beats/minute
Standard Deviation 12.47
|
73.9 beats/minute
Standard Deviation 10.83
|
74.2 beats/minute
Standard Deviation 11.22
|
|
Change From Baseline in Pulse Rate
Change from Baseline to End of Study
|
-0.2 beats/minute
Standard Deviation 10.69
|
-0.8 beats/minute
Standard Deviation 9.83
|
0.9 beats/minute
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using last observation carried forward (LOCF).
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who selected 1=not at all pronounced, 2=mildly pronounced, or 3=moderately pronounced are reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant
|
47.8 percentage of participants
Interval 33.4 to 62.3
|
96.2 percentage of participants
Interval 91.1 to 100.0
|
93.5 percentage of participants
Interval 86.3 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using LOCF.
The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the investigator are reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
|
10.9 percentage of participants
Interval 1.9 to 19.9
|
66.0 percentage of participants
Interval 53.3 to 78.8
|
71.7 percentage of participants
Interval 58.7 to 84.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using LOCF.
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the participant are reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
|
32.6 percentage of participants
Interval 19.1 to 46.2
|
86.8 percentage of participants
Interval 77.7 to 95.9
|
80.4 percentage of participants
Interval 69.0 to 91.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using LOCF.
The participants assessed the degree of change of their MMP using a single item composed of 7 grades (3 to -3) where: 3=much improved, 2=moderately improved, 1=minimally improved, 0=no change, -1=minimally worse, -2=moderately worse, and -3=much worse. The percentage of participants where the participant selected 2=moderately improved, or 3=much improved as compared to Baseline are reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90
|
21.7 percentage of participants
Interval 9.8 to 33.7
|
90.6 percentage of participants
Interval 82.7 to 98.4
|
73.9 percentage of participants
Interval 61.2 to 86.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using LOCF.
Lower facial volume was calculated from 3-dimensional (3D) surface images captured at Baseline and Day 90. The analysis region is defined using a series of anatomical landmarks placed on the baseline surface that are then projected mathematically to the posttreatment surface and verified by a technician. The difference in volume is measured between the select region of the baseline surface to the posttreatment surface. The lower facial volume is summed for both the left side and the right side of the face. An analysis of covariance (ANCOVA) model was used for analyses.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
|
-0.33 cubic centimeter (cm^3)
Standard Error 0.511
|
-6.15 cubic centimeter (cm^3)
Standard Error 0.475
|
-6.14 cubic centimeter (cm^3)
Standard Error 0.505
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 90Population: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment. Missing postbaseline data are imputed using LOCF.
Lower facial volume was calculated from 3D surface models of the full area of the lower face captured at Baseline and Day 90. The statistical MMP AOI method is based on a statistical shape averaging of the area of change post masseter treatment from multiple facial models. The difference in volume is calculated between the two 3D surface models at Baseline and Day 90. An ANCOVA model was used for analyses.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=46 Participants
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
|
-0.09 cm^3
Standard Error 0.598
|
-7.72 cm^3
Standard Error 0.555
|
-8.35 cm^3
Standard Error 0.590
|
Adverse Events
Placebo
BOTOX® 48U
BOTOX® 72U
Serious adverse events
| Measure |
Placebo
n=48 participants at risk
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.1%
1/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
1.9%
1/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
1.9%
1/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
Other adverse events
| Measure |
Placebo
n=48 participants at risk
Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 48U
n=53 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
BOTOX® 72U
n=49 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
5.7%
3/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
2.0%
1/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
5.7%
3/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/48 • First dose (Day 1) to the End of Study (Up to Day 180)
|
0.00%
0/53 • First dose (Day 1) to the End of Study (Up to Day 180)
|
6.1%
3/49 • First dose (Day 1) to the End of Study (Up to Day 180)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER