Trial Outcomes & Findings for Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis (NCT NCT03137407)
NCT ID: NCT03137407
Last Updated: 2023-09-18
Results Overview
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Week 8
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
DAXI 240 U
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
|
Placebo
Placebo group
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Baseline characteristics by cohort
| Measure |
DAXI 240 U
n=30 Participants
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
|
Placebo
n=29 Participants
Placebo group
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Age, Customized
<30
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
30 - <40
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Customized
40 - <50
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
50 - <60
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Customized
>=60
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race/Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Intent to treat population
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Outcome measures
| Measure |
DaxibotulinumtoxinA 240 Units
n=30 Participants
Botulinum Toxins, Type A Intramuscular Injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=29 Participants
Placebo Intramuscular Injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
|
-41.6 score on a scale
Standard Deviation 30.04
|
-39.3 score on a scale
Standard Deviation 32.54
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 16Population: Intent to treat population
Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Outcome measures
| Measure |
DaxibotulinumtoxinA 240 Units
n=30 Participants
Botulinum Toxins, Type A Intramuscular Injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=29 Participants
Placebo Intramuscular Injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Week 1
|
-27.4 score on a scale
Standard Deviation 28.92
|
-21.6 score on a scale
Standard Deviation 26.79
|
|
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Week 2
|
-31.6 score on a scale
Standard Deviation 29.97
|
-29.6 score on a scale
Standard Deviation 27.33
|
|
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Week 4
|
-37.9 score on a scale
Standard Deviation 27.15
|
-31.4 score on a scale
Standard Deviation 28.96
|
|
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Week 8
|
-41.6 score on a scale
Standard Deviation 30.04
|
-39.3 score on a scale
Standard Deviation 32.54
|
|
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Week 16
|
-44.7 score on a scale
Standard Deviation 32.82
|
-46.3 score on a scale
Standard Deviation 30.40
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 16Population: Intent to treat population
The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
DaxibotulinumtoxinA 240 Units
n=30 Participants
Botulinum Toxins, Type A Intramuscular Injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=29 Participants
Placebo Intramuscular Injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Week 1
|
12.4 score on a scale
Standard Deviation 17.56
|
15.5 score on a scale
Standard Deviation 16.85
|
|
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Week 2
|
14.3 score on a scale
Standard Deviation 20.32
|
18.5 score on a scale
Standard Deviation 16.85
|
|
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Week 4
|
19.4 score on a scale
Standard Deviation 22.76
|
21.2 score on a scale
Standard Deviation 20.06
|
|
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Week 8
|
20.4 score on a scale
Standard Deviation 23.64
|
23.6 score on a scale
Standard Deviation 24.88
|
|
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Week 16
|
25.7 score on a scale
Standard Deviation 23.41
|
23.1 score on a scale
Standard Deviation 24.05
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 16Population: Intent to treat population
The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.
Outcome measures
| Measure |
DaxibotulinumtoxinA 240 Units
n=30 Participants
Botulinum Toxins, Type A Intramuscular Injection
Botulinum Toxins, Type A: Intramuscular injection
|
Placebo
n=29 Participants
Placebo Intramuscular Injection
Placebo: Intramuscular injection
|
|---|---|---|
|
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Week 1
|
9.1 score on a scale
Standard Deviation 16.63
|
14.5 score on a scale
Standard Deviation 14.87
|
|
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Week 2
|
10.4 score on a scale
Standard Deviation 16.93
|
16.5 score on a scale
Standard Deviation 14.12
|
|
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Week 4
|
16.4 score on a scale
Standard Deviation 20.66
|
19.3 score on a scale
Standard Deviation 14.21
|
|
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Week 8
|
19.1 score on a scale
Standard Deviation 20.98
|
19.7 score on a scale
Standard Deviation 15.71
|
|
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Week 16
|
21.7 score on a scale
Standard Deviation 22.60
|
23.2 score on a scale
Standard Deviation 17.86
|
Adverse Events
DAXI 240 U
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DAXI 240 U
n=30 participants at risk
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
|
Placebo
n=29 participants at risk
Placebo group
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
1/30 • Number of events 1 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
0.00%
0/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
Other adverse events
| Measure |
DAXI 240 U
n=30 participants at risk
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
|
Placebo
n=29 participants at risk
Placebo group
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
General disorders
Injection Site Hemorrhage
|
10.0%
3/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
General disorders
Injection Site Pain
|
20.0%
6/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
20.7%
6/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
General disorders
Injection site bruising
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
3.4%
1/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
General disorders
Injection site edema
|
0.00%
0/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
General disorders
Injection site erythema
|
0.00%
0/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Infections and infestations
Paronychia
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
0.00%
0/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
3.4%
1/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
0.00%
0/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
0.00%
0/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
2/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
3.4%
1/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
6/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
10.3%
3/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
6.9%
2/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
|
Nervous system disorders
Hypoaesthesia
|
13.3%
4/30 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
0.00%
0/29 • Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
|
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