Trial Outcomes & Findings for Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity (NCT NCT03821402)
NCT ID: NCT03821402
Last Updated: 2023-09-21
Results Overview
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Week 6
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
DAXI 250 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
Placebo group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
19
|
18
|
24
|
|
Overall Study
COMPLETED
|
15
|
12
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<= 50 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
> 50 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not provided
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Intent to treat population
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
|
-0.9 score on a scale
Standard Error 0.25
|
-1.0 score on a scale
Standard Error 0.26
|
-1.5 score on a scale
Standard Error 0.27
|
-0.8 score on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Week 6Population: Intent to treat population
Mean score on the Physician Global Impression of Change (PGIC) score at week 6. The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved).
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Physician Global Impression of Change (PGIC) Score
|
1.5 score on a scale
Standard Error 0.29
|
1.7 score on a scale
Standard Error 0.30
|
1.7 score on a scale
Standard Error 0.32
|
1.2 score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: Intent to treat population
Percentage of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part(s) rigid in flexion or extension)
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Muscle Tone Improvement Responder Rate
Week 6
|
13 Participants
|
11 Participants
|
11 Participants
|
8 Participants
|
|
Muscle Tone Improvement Responder Rate
Week 12
|
9 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: Intent to treat population
Percentage of subjects with improvement (i.e., a score of 1 to 4) on the Physician Global Impression of Change (PGIC). The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved). Scores of 1 or more indicate improvement following treatment.
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Physician Global Impression of Change (PGIC) Responder Rate
Week 6
|
17 Participants
|
16 Participants
|
14 Participants
|
15 Participants
|
|
Physician Global Impression of Change (PGIC) Responder Rate
Week 12
|
15 Participants
|
17 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Weeks 6 and 12Population: Intent to treat population
Change from Baseline at Weeks 6 and 12 in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). DAS score range: 0 (No disability) to 3 (Severe disability - normal activities limited).
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
Week 6
|
-0.9 score on a scale
Standard Error 0.19
|
-1.2 score on a scale
Standard Error 0.19
|
-0.7 score on a scale
Standard Error 0.21
|
-0.50 score on a scale
Standard Error 0.20
|
|
Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
Week 12
|
-0.7 score on a scale
Standard Error 0.21
|
-1.0 score on a scale
Standard Error 0.22
|
-0.5 score on a scale
Standard Error 0.21
|
-0.8 score on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: Intent to treat population
Duration of effect is defined as time from injection (in weeks) until loss of muscle tone improvement in the SMG, as indicated by a reduction from baseline in MAS score of \< 1-point and PGIC score is ≤ 0.
Outcome measures
| Measure |
DAXI 250 U
n=9 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=10 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=9 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=19 Participants
Placebo group
|
|---|---|---|---|---|
|
Duration of Effect
|
NA weeks
Interval 13.0 to
Insufficient subjects with an observed event
|
24.0 weeks
Interval 15.3 to
Insufficient subjects with an observed event
|
24.7 weeks
Interval 5.7 to
Insufficient subjects with an observed event
|
8.4 weeks
Interval 2.0 to 27.1
|
POST_HOC outcome
Timeframe: Week 4Population: Intent to treat population
Mean change from baseline at Week 4 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Change From Baseline at Week 4 in the Suprahypertonic Muscle Group (SMG) Score
|
-0.9 score on a scale
Standard Error 0.22
|
-0.9 score on a scale
Standard Error 0.23
|
-1.8 score on a scale
Standard Error 0.24
|
-0.6 score on a scale
Standard Error 0.22
|
POST_HOC outcome
Timeframe: Week 4Population: Intent to treat population
Change from Baseline at Week 4 in the Physician Global Impression of Change (PGIC). Score range: -4 (Markedly worse) to +4 (Markedly improved).
Outcome measures
| Measure |
DAXI 250 U
n=22 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 Participants
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 Participants
Placebo group
|
|---|---|---|---|---|
|
Change From Baseline at Week 4 in the Physician Global Impression of Change (PGIC) Score
|
1.5 score on a scale
Standard Error 0.24
|
1.7 score on a scale
Standard Error 0.24
|
1.8 score on a scale
Standard Error 0.26
|
0.9 score on a scale
Standard Error 0.23
|
Adverse Events
DAXI 250 U
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
DAXI 375 U
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DAXI 500 U
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DAXI 250 U
n=22 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 participants at risk
Placebo group
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Infections and infestations
Coronavirus infection
|
4.5%
1/22 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.5%
1/22 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Nervous system disorders
Seizure
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
Other adverse events
| Measure |
DAXI 250 U
n=22 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U
|
DAXI 375 U
n=19 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
|
DAXI 500 U
n=18 participants at risk
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
|
Placebo
n=24 participants at risk
Placebo group
|
|---|---|---|---|---|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
2/22 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Eye disorders
Vision blurred
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
10.5%
2/19 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Influenza like illness
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Injection site bruising
|
4.5%
1/22 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Injection site erythema
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Injection site hematoma
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Injection site induration
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
General disorders
Injection site swelling
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Infections and infestations
Nail infection
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22 • Number of events 3 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
4.2%
1/24 • Number of events 2 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/19 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.6%
1/18 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/22 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
5.3%
1/19 • Number of events 1 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/18 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
0.00%
0/24 • The adverse events were collected throughout the entire study, up to 36 weeks.
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
|
Additional Information
Todd Gross, PhD, VP, Clinical Development & Data Science
Revance Therapeutics, Inc.
Phone: 510-742-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
- Publication restrictions are in place
Restriction type: OTHER