Phase 2
N=155
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Plantar Fasciitis
Bottom Line
View on ClinicalTrials.gov: NCT03825315 ↗Enrolled (actual)
155
Serious AEs
2.6%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score — -3.29; -3.25; -2.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DAXI 80 U (Biological); DAXI 120 U (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Revance Therapeutics, Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score |
-3.29; -3.25; -2.75 | — |
| SECONDARY Change From Baseline at Week 8 in Foot Function Index (FFI) |
-29.02; -27.37; -23.63 | — |
| SECONDARY Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS |
35; 41; 34 | — |
Summary
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of 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 unilateral plantar fasciitis.
- Persistent heel pain.
- Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.
Exclusion Criteria
- Previous injection of botulinum toxin in the lower extremities or feet.
- Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation.
- Pregnant, nursing, or 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.
- Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.
Data sourced from ClinicalTrials.gov (NCT03825315). 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.