Trial Outcomes & Findings for DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis (NCT NCT03825315)

Last Updated: 2023-09-21

Results Overview

Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

155 participants

Primary outcome timeframe

Week 8

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	DAXI 80 U DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)	Placebo Placebo Group.
Overall Study STARTED	49	54	52
Overall Study COMPLETED	42	48	46
Overall Study NOT COMPLETED	7	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DAXI 80 U n=49 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 Participants Placebo Group	Total n=155 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 9.06 • n=5 Participants	47.1 years STANDARD_DEVIATION 8.17 • n=7 Participants	48.5 years STANDARD_DEVIATION 8.02 • n=5 Participants	48.1 years STANDARD_DEVIATION 8.38 • n=4 Participants
Age, Customized <= 50 years	26 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	94 Participants n=4 Participants
Age, Customized > 50 years	23 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	36 Participants n=5 Participants	103 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	22 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	44 Participants n=5 Participants	44 Participants n=7 Participants	47 Participants n=5 Participants	135 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	DAXI 80 U n=49 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 Participants Placebo Group.
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score	-3.29 score on a scale Standard Error 0.329	-3.25 score on a scale Standard Error 0.298	-2.75 score on a scale Standard Error 0.302

SECONDARY outcome

Timeframe: Week 8

Population: Intent to treat population

The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100.

Outcome measures

Outcome measures
Measure	DAXI 80 U n=49 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 Participants Placebo Group.
Change From Baseline at Week 8 in Foot Function Index (FFI)	-29.02 score on a scale Standard Error 2.202	-27.37 score on a scale Standard Error 2.149	-23.63 score on a scale Standard Error 2.185

SECONDARY outcome

Timeframe: Week 8

Population: Intent to treat population

For the proportion of subjects with a decrease from baseline of \>= 20% in NPRS score at Week 8

Outcome measures

Outcome measures
Measure	DAXI 80 U n=49 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 Participants DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 Participants Placebo Group.
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	35 Participants	41 Participants	34 Participants

Adverse Events

DAXI 80 U

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

DAXI 120 U

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DAXI 80 U n=49 participants at risk DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 participants at risk DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 participants at risk Placebo Group
Infections and infestations Infectious mononucleosis	2.0% 1/49 • Number of events 1 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/54 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/52 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/49 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	1.9% 1/54 • Number of events 1 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/52 • The adverse events were collected throughout the entire study, through week 24. 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 Nephrolithiasis	0.00% 0/49 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	1.9% 1/54 • Number of events 1 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/52 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
Reproductive system and breast disorders Uterine haemorrhage	2.0% 1/49 • Number of events 1 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/54 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	0.00% 0/52 • The adverse events were collected throughout the entire study, through week 24. 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

Other adverse events
Measure	DAXI 80 U n=49 participants at risk DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)	DAXI 120 U n=54 participants at risk DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group)	Placebo n=52 participants at risk Placebo Group
Infections and infestations Nasopharyngitis	4.1% 2/49 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.6% 3/54 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.8% 3/52 • Number of events 5 • The adverse events were collected throughout the entire study, through week 24. 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 Influenza	4.1% 2/49 • Number of events 2 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	7.4% 4/54 • Number of events 4 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.8% 3/52 • Number of events 4 • The adverse events were collected throughout the entire study, through week 24. 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	2.0% 1/49 • Number of events 1 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.6% 3/54 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	3.8% 2/52 • Number of events 2 • The adverse events were collected throughout the entire study, through week 24. 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 pain	6.1% 3/49 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.6% 3/54 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	5.8% 3/52 • Number of events 3 • The adverse events were collected throughout the entire study, through week 24. 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.
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Restriction type: OTHER