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

Revance Therapeutics, Inc.5 sites in 1 country59 target enrollmentJune 12, 2017

ConditionsPlantar Fasciitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Plantar Fasciitis
Sponsor: Revance Therapeutics, Inc.
Enrollment: 59
Locations: 5
Primary Endpoint: Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
Status: Completed
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

June 12, 2017

End Date

February 20, 2018

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
•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

Outcomes

Primary Outcomes

Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot

Time Frame: Week 8

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 Outcomes

Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)(Weeks 1, 2, 4, 8, and 16)
Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16(Weeks 1, 2, 4, 8, and 16)
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index(Weeks 1, 2, 4, 8, and 16)