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Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxins, Type A
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 heel pain

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 plantar fasciitis
  • Persistent heel pain for more than three months
  • Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study

Exclusion Criteria:

  • Previous surgery on the midfoot or hindfoot
  • Neuromuscular disease
  • Systemic muscle weakness
  • 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

Sites / Locations

  • Village Podiatry Centers
  • Weil Foot and Ankle Institute
  • Kansas City Bone & Joint Clinic
  • Wake Forest Baptist Medical Center
  • Element Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAXI 240 U

Placebo

Arm Description

DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U

Placebo Intramuscular Injection

Outcomes

Primary Outcome Measures

Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.

Secondary Outcome Measures

Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.

Full Information

First Posted
April 27, 2017
Last Updated
August 28, 2023
Sponsor
Revance Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03137407
Brief Title
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Official Title
A Phase 2, Prospective, Randomized, Double-Blinded, 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
June 12, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
heel pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAXI 240 U
Arm Type
Experimental
Arm Description
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Intramuscular Injection
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxins, Type A
Other Intervention Name(s)
DaxibotulinumtoxinA
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
Description
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
Description
Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Time Frame
Weeks 1, 2, 4, 8, and 16
Title
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
Description
The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Time Frame
Weeks 1, 2, 4, 8, and 16
Title
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
Description
The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.
Time Frame
Weeks 1, 2, 4, 8, and 16

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 plantar fasciitis Persistent heel pain for more than three months Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study Exclusion Criteria: Previous surgery on the midfoot or hindfoot Neuromuscular disease Systemic muscle weakness 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
Facility Information:
Facility Name
Village Podiatry Centers
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Weil Foot and Ankle Institute
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Kansas City Bone & Joint Clinic
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Element Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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