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DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
daxibotulinumtoxin 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

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
  • Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at Screening Visit 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

  • Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

daxibotulinumtoxinA (DAXI) for injection

Placebo

Arm Description

DAXI for injection

Placebo Intramuscular injection

Outcomes

Primary Outcome Measures

Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)

Secondary Outcome Measures

Reduction in the visual analog pain score for the foot

Full Information

First Posted
November 22, 2016
Last Updated
November 11, 2019
Sponsor
Revance Therapeutics, Inc.
Collaborators
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02973269
Brief Title
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
November 2019
Overall Recruitment Status
Terminated
Why Stopped
New trial with same indication initiated
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revance Therapeutics, Inc.
Collaborators
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
No

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
daxibotulinumtoxinA (DAXI) for injection
Arm Type
Experimental
Arm Description
DAXI for injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
daxibotulinumtoxin type A
Other Intervention Name(s)
DAXI
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Reduction in the visual analog pain score for the foot
Time Frame
16 weeks

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 Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at Screening Visit 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
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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