A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Revance Therapeutics, Inc.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DAXI 240 U
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
Intervention: daxibotulinumtoxin type A (Biological)
Placebo
Placebo Intramuscular injection
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
Time Frame: 16 weeks
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.
Secondary Outcomes
No secondary outcomes reported