Study Stopped
New trial with same indication initiated
DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2016
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedResults Posted
Study results publicly available
April 3, 2024
CompletedApril 3, 2024
March 1, 2024
7 months
November 22, 2016
June 2, 2023
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function.
16 weeks
Study Arms (2)
DAXI 240 U
EXPERIMENTALDaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
Placebo
PLACEBO COMPARATORPlacebo Intramuscular injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Revance Therapeutics, Inc.lead
- Wake Forest University Health Sciencescollaborator
Study Sites (1)
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Todd Gross, PhD, VP, Clinical Development & Data Science
- Organization
- Revance Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 25, 2016
Study Start
November 14, 2016
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
April 3, 2024
Results First Posted
April 3, 2024
Record last verified: 2024-03