DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Revance Therapeutics, Inc.155 enrolled

Overview

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.

Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

155

Conditions

Plantar Fasciitis

Interventions

DAXI 80 UBIOLOGICAL

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)

DAXI 120 UBIOLOGICAL

DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)

PlaceboOTHER

Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (20)

Aung Foot Health Clinic

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score

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.

Time frame: Week 8

Secondary Outcomes

Change From Baseline at Week 8 in Foot Function Index (FFI)

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.

Time frame: Week 8

Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS

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

Time frame: Week 8

Data from ClinicalTrials.gov

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