DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Phase 2

Completed

• Conditions: Plantar Fasciitis
• Interventions: Biological: DAXI 80 U; Other: Placebo; Biological: DAXI 120 U

• Registration Number: NCT03825315
• Lead Sponsor: Revance Therapeutics, Inc.

Brief 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.

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 Timeline

• Study Start: 2018-12-31
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Primary Completion: 2020-06-04
• Study Completion: 2020-06-04
• Disposition First Submitted: 2021-02-11
• Results First Submitted: 2023-06-02
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Results First Posted: 2023-09-21
• Disposition First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAXI 80 U	DAXI 80 U	LOW Dose Group
Placebo	Placebo	Placebo Group.
DAXI 120 U	DAXI 120 U	HIGH Dose Group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS	Week 8	For the proportion of subjects with a decrease from baseline of \>= 20% in NPRS score at Week 8
Change From Baseline at Week 8 in Foot Function Index (FFI)	Week 8	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.

Trial Locations

Locations (19)

Kansas Institute of Research; 🇺🇸 Overland Park, Kansas, United States

Advanced Foot & Ankle Center; 🇺🇸 Las Vegas, Nevada, United States

Rocky Mountain Foot and Ankle, LLC; 🇺🇸 Salt Lake City, Utah, United States

Strash Foot and Ankle Care; 🇺🇸 San Antonio, Texas, United States

Podiatry 1st; 🇺🇸 Belleville, Illinois, United States

North Texas Institute of Neurology and Headache; 🇺🇸 Frisco, Texas, United States

Bay Area Foot Care; 🇺🇸 San Francisco, California, United States

Foot and Ankle Clinic; 🇺🇸 Los Angeles, California, United States

Sacramento Foot and Ankle Center, Inc; 🇺🇸 Carmichael, California, United States

LA Podiatry Group; 🇺🇸 West Palm Beach, Florida, United States

Aung Foot Health Clinic; 🇺🇸 Tucson, Arizona, United States

West Coast Foot and Ankle; 🇺🇸 Huntington Beach, California, United States

Rosalind Franklin University of Medicine & Science; 🇺🇸 North Chicago, Illinois, United States

Futuro Clinical Trials, LLC; 🇺🇸 McAllen, Texas, United States

Hermann Drive Research Hospital; 🇺🇸 Houston, Texas, United States

Medical Research International; 🇺🇸 Oklahoma City, Oklahoma, United States

The Podiatry Group of South Texas; 🇺🇸 San Antonio, Texas, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

University Foot and Ankle Foundation; 🇺🇸 Santa Monica, California, United States