Phase 2 N=59 Randomized Quadruple-blind Treatment

Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Plantar Fasciitis

Bottom Line

View on ClinicalTrials.gov: NCT03137407 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Aug 2023

Primary outcome: Primary: Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot — -41.6; -39.3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Botulinum Toxins, Type A (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Revance Therapeutics, Inc.
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot	-41.6; -39.3	—
SECONDARY Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16	-27.4; -21.6; -31.6; -29.6; -37.9; -31.4	—
SECONDARY Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)	12.4; 15.5; 14.3; 18.5; 19.4; 21.2	—
SECONDARY Change From Baseline Through Week 16 for the Foot and Ankle Disability Index	9.1; 14.5; 10.4; 16.5; 16.4; 19.3	—

Summary

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

Eligibility Criteria

Inclusion Criteria

Written informed consent, including authorization to release health information
Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
Persistent heel pain for more than three months
Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study

Exclusion Criteria

Previous surgery on the midfoot or hindfoot
Neuromuscular disease
Systemic muscle weakness
Planning a pregnancy during the study
Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03137407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.