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DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DAXI 80 U
DAXI 120 U
Placebo
Sponsored by
Revance Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aung Foot Health Clinic
  • Sacramento Foot and Ankle Center, Inc
  • Bay Area Foot Care
  • West Coast Foot and Ankle
  • Foot and Ankle Clinic
  • Bay Area Foot Care
  • University Foot and Ankle Foundation
  • LA Podiatry Group
  • Podiatry 1st
  • Rosalind Franklin University of Medicine & Science
  • Kansas Institute of Research
  • Advanced Foot & Ankle Center
  • Medical Research International
  • North Texas Institute of Neurology and Headache
  • Hermann Drive Research Hospital
  • Futuro Clinical Trials, LLC
  • Strash Foot and Ankle Care
  • The Podiatry Group of South Texas
  • Rocky Mountain Foot and Ankle, LLC
  • Wasatch Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DAXI 80 U

DAXI 120 U

Placebo

Arm Description

LOW Dose Group

HIGH Dose Group

Placebo Group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 15, 2019
Last Updated
August 24, 2023
Sponsor
Revance Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03825315
Brief Title
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Official Title
A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
June 4, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revance Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blinded
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAXI 80 U
Arm Type
Experimental
Arm Description
LOW Dose Group
Arm Title
DAXI 120 U
Arm Type
Experimental
Arm Description
HIGH Dose Group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Group.
Intervention Type
Biological
Intervention Name(s)
DAXI 80 U
Intervention Description
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
Intervention Type
Biological
Intervention Name(s)
DAXI 120 U
Intervention Description
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score
Description
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 Outcome Measure Information:
Title
Change From Baseline at Week 8 in Foot Function Index (FFI)
Description
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
Title
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS
Description
For the proportion of subjects with a decrease from baseline of >= 20% in NPRS score at Week 8
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aung Foot Health Clinic
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Sacramento Foot and Ankle Center, Inc
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Bay Area Foot Care
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
West Coast Foot and Ankle
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Bay Area Foot Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University Foot and Ankle Foundation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
LA Podiatry Group
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Podiatry 1st
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Rosalind Franklin University of Medicine & Science
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Kansas Institute of Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1358
Country
United States
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Medical Research International
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Hermann Drive Research Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Futuro Clinical Trials, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Strash Foot and Ankle Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
The Podiatry Group of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78295
Country
United States
Facility Name
Rocky Mountain Foot and Ankle, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

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