Trial Outcomes & Findings for A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence (NCT NCT05134649)
NCT ID: NCT05134649
Last Updated: 2024-12-05
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
292 participants
Primary outcome timeframe
371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
Results posted on
2024-12-05
Participant Flow
A total of 292 participants were enrolled at 28 sites in the United States and Canada. All participants received at least 1 dose of open-label BOTOX and were included in the intent-to-treat (ITT) and safety populations.
Safety analyses were carried out for the Safety Analysis Set (Safety Population), which consisted of all participants who received study drug in both the lead-in study and in this study (N=292).
Participant milestones
| Measure |
BOTOX
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323.
|
|---|---|
|
Overall Study
STARTED
|
292
|
|
Overall Study
COMPLETED
|
262
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
BOTOX
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Other, not specified
|
3
|
Baseline Characteristics
A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Baseline characteristics by cohort
| Measure |
BOTOX
n=292 Participants
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
278 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
49.6 Years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
261 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
265 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)Population: Safety Analysis Set
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Outcome measures
| Measure |
Placebo (Lead-in)
n=151 Participants
Participants who received placebo in M21-309 until they received their first BOTOX treatment or discontinued in M21-323.
|
BOTOX (Cycle 1)
n=292 Participants
Participants who received their first BOTOX treatment until they received their next BOTOX treatment or discontinued in M21-323.
The first BOTOX treatment may have been in M21-309 or M21-323.
|
BOTOX (Cycle 2)
n=268 Participants
Participants who received their second BOTOX treatment until they received their next BOTOX treatment or discontinued in M21-323.
The first BOTOX treatment may have been in M21-309 or M21-323.
|
BOTOX (Cycle 3)
n=177 Participants
Participants who received their third BOTOX treatment until they received their next BOTOX treatment or discontinued in M21-323.
The first BOTOX treatment may have been in M21-309 or M21-323.
|
BOTOX (Cycle 4)
n=54 Participants
Participants who received their fourth BOTOX treatment until they until they discontinued or completed M21-323.
The first BOTOX treatment was administered in M21-309.
|
BOTOX (All Treatment Cycles)
n=292 Participants
Participants who received at least one BOTOX treatment in either M21-309 or M21-323 and were enrolled in M21-323.
|
Total
n=292 Participants
Participants who received any study drug in either M21-309 or M21-323 and were enrolled in M21-323.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
33 Participants
|
74 Participants
|
46 Participants
|
26 Participants
|
11 Participants
|
111 Participants
|
127 Participants
|
Adverse Events
BOTOX
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX
n=292 participants at risk
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323.
|
|---|---|
|
Infections and infestations
CELLULITIS
|
0.34%
1/292 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.34%
1/292 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
|
Other adverse events
| Measure |
BOTOX
n=292 participants at risk
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323.
|
|---|---|
|
General disorders
INJECTION SITE BRUISING
|
4.1%
12/292 • Number of events 13 • All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
|
|
Infections and infestations
COVID-19
|
7.5%
22/292 • Number of events 22 • All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.1%
12/292 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER