DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Placebo; Biological: DAXI 80 U; Biological: DAXI 120 U

Detailed Description

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
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Aung Foot Health Clinic
  • California
    • Carmichael, California, United States, 95608
      • Sacramento Foot and Ankle Center, Inc
    • Castro Valley, California, United States, 94546
      • Bay Area Foot Care
    • Huntington Beach, California, United States, 92648
      • West Coast Foot and Ankle
    • Los Angeles, California, United States, 90057
      • Foot and Ankle Clinic
    • San Francisco, California, United States, 94115
      • Bay Area Foot Care
    • Santa Monica, California, United States, 90403
      • University Foot and Ankle Foundation
  • Florida
    • West Palm Beach, Florida, United States, 33406
      • LA Podiatry Group
  • Illinois
    • Belleville, Illinois, United States, 62226
      • Podiatry 1st
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University of Medicine & Science
  • Kansas
    • Overland Park, Kansas, United States, 66211-1358
      • Kansas Institute of Research
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Advanced Foot & Ankle Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Medical Research International
  • Texas
    • Frisco, Texas, United States, 75034
      • North Texas Institute of Neurology and Headache
    • Houston, Texas, United States, 77004
      • Hermann Drive Research Hospital
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials, LLC
    • San Antonio, Texas, United States, 78209
      • Strash Foot and Ankle Care
    • San Antonio, Texas, United States, 78295
      • The Podiatry Group of South Texas
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Foot and Ankle, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Group.	Other: Placebo; 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.
Experimental: DAXI 80 U; LOW Dose Group	Biological: DAXI 80 U; DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
Experimental: DAXI 120 U; HIGH Dose Group	Biological: DAXI 120 U; DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate improvement on the Clinical Global Impression of Change (CGIC)	Proportion of subjects with improvement on the Clinical Global Impression of Change (CGIC) over time	All post treatment time points (approximately 6 months)
Improvement on the the Patient Global Impression of Change (PGIC)	Proportion of subjects with improvement on the Patient Global Impression of Change (PGIC) over time	All post treatment time points (approximately 6 months)

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: DAXI for injection,; Plantar Fasciitis,; Heel Pain,; BotulinumtoxinA
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 1820201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No