A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Revance Therapeutics, Inc.1 site in 1 country7 target enrollmentNovember 14, 2016

ConditionsPlantar Fasciitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Plantar Fasciitis
Sponsor: Revance Therapeutics, Inc.
Enrollment: 7
Locations: 1
Primary Endpoint: Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 14, 2016

End Date

May 31, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Revance Therapeutics, Inc.

Responsible Party

Sponsor

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

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.