Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Revance Therapeutics, Inc.59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Plantar Fasciitis

Interventions

Botulinum Toxins, Type ABIOLOGICAL

Intramuscular injection

PlaceboBIOLOGICAL

Intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Village Podiatry Centers

Duluth, Georgia, United States

Weil Foot and Ankle Institute

Des Plaines, Illinois, United States

Kansas City Bone & Joint Clinic

Overland Park, Kansas, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Week 8

Secondary Outcomes

Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16

Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. 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.

Time frame: Weeks 1, 2, 4, 8, and 16

Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)

The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.

Time frame: Weeks 1, 2, 4, 8, and 16

Change From Baseline Through Week 16 for the Foot and Ankle Disability Index

The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.

Time frame: Weeks 1, 2, 4, 8, and 16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.