Trial Outcomes & Findings for DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis (NCT NCT02973269)

Last Updated: 2024-04-03

Results Overview

The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-04-03

Participant Flow

Participant milestones

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	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 16 weeks

Population: The Intent-to-Treat population includes all patients randomized to treatment.

Outcome measures

Outcome measures
Measure	DAXI 240 U n=3 Participants DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U	Placebo n=4 Participants Placebo group
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)	81.3 units on a scale Standard Deviation 11.0	86.5 units on a scale Standard Deviation 12.1

Adverse Events

DAXI 240 U

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DAXI 240 U n=3 participants at risk DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U	Placebo n=4 participants at risk Placebo group
Musculoskeletal and connective tissue disorders Weakness	0.00% 0/3 • Up to 16 weeks The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs	25.0% 1/4 • Number of events 1 • Up to 16 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 Muscle cramps	33.3% 1/3 • Number of events 1 • Up to 16 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% 0/4 • Up to 16 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 Headache	33.3% 1/3 • Number of events 1 • Up to 16 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% 0/4 • Up to 16 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 (45) 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

Measure	DAXI 240 U n=3 Participants DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U	Placebo n=4 Participants Placebo group	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
AOFAS total score	71.3 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	66.0 units on a scale STANDARD_DEVIATION 21.7 • n=7 Participants	68.3 units on a scale STANDARD_DEVIATION 15.2 • n=5 Participants