DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Sponsor

Revance Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03825315

Collaborator

(none)

155

Enrollment

Locations

Arms

17.1

Actual Duration (Months)

7.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis	Biological: DAXI for Injection: LOW Dose Other: DAXI for Injection: HIGH Dose Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, PlaceboSubjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 31, 2018

Actual Primary Completion Date :

Jun 4, 2020

Actual Study Completion Date :

Jun 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAXI for Injection: LOW Dose LOW Dose Group	Biological: DAXI for Injection: LOW Dose DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Experimental: DAXI for Injection: HIGH Dose HIGH Dose Group	Other: DAXI for Injection: HIGH Dose DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
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.

Arm

Intervention/Treatment

Experimental: DAXI for Injection: LOW Dose

LOW Dose Group

Biological: DAXI for Injection: LOW Dose

DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.

Experimental: DAXI for Injection: HIGH Dose

HIGH Dose Group

Other: DAXI for Injection: HIGH Dose

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in the Numeric Pain Rating Scale (NPRS) score [Week 8]
Change from baseline in the Numeric Pain Rating Scale (NPRS) score (Scale Range: 0 {No pain} to 10 {Worst pain imaginable})

Secondary Outcome Measures

Change from baseline in Foot Function Index (FFI) [All post treatment time points (approximately 6 months)]
Change from baseline in Foot Function Index (FFI) (Pain Sub-Scale Range: 0 {No pain} to 10 {Worst pain imaginable}, Disability Sub-Scale Range: 0 {No difficulty} to 10 {So difficult unable to do so}, Activity Limitation Sub-Scale Range: 0 {None of the time} to 10 {All of the time})

Other Outcome Measures

Moderate improvement on the Clinical Global Impression of Change (CGIC) [All post treatment time points (approximately 6 months)]
Proportion of subjects with improvement on the Clinical Global Impression of Change (CGIC) over time
Improvement on the the Patient Global Impression of Change (PGIC) [All post treatment time points (approximately 6 months)]
Proportion of subjects with improvement on the Patient Global Impression of Change (PGIC) over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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