DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825315
• Other study ID #: 1820201
• Status: Completed
• Phase: Phase 2
• Start date: December 31, 2018
• Est. completion date: June 4, 2020

Study information

• Verified date: August 2023
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Biological:
• DAXI 80 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
• DAXI 120 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose 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.

Locations

Country	Name	City	State
United States	Podiatry 1st	Belleville	Illinois
United States	Sacramento Foot and Ankle Center, Inc	Carmichael	California
United States	Bay Area Foot Care	Castro Valley	California
United States	North Texas Institute of Neurology and Headache	Frisco	Texas
United States	Hermann Drive Research Hospital	Houston	Texas
United States	West Coast Foot and Ankle	Huntington Beach	California
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	Foot and Ankle Clinic	Los Angeles	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	Rosalind Franklin University of Medicine & Science	North Chicago	Illinois
United States	Medical Research International	Oklahoma City	Oklahoma
United States	Kansas Institute of Research	Overland Park	Kansas
United States	Rocky Mountain Foot and Ankle, LLC	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Strash Foot and Ankle Care	San Antonio	Texas
United States	The Podiatry Group of South Texas	San Antonio	Texas
United States	Bay Area Foot Care	San Francisco	California
United States	University Foot and Ankle Foundation	Santa Monica	California
United States	Aung Foot Health Clinic	Tucson	Arizona
United States	LA Podiatry Group	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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