DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Phase 2

Terminated

• Conditions: Plantar Fasciitis
• Interventions: Biological: daxibotulinumtoxin type A; Biological: Placebo

• Registration Number: NCT02973269
• Lead Sponsor: Revance Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-14
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Disposition First Submitted: 2019-11-11
• Disposition First Submitted QC: 2019-11-11
• Disposition First Posted: 2019-11-15
• Results First Submitted: 2023-06-02
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Results First Posted: 2024-04-03
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAXI 240 U	daxibotulinumtoxin type A	DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
Placebo	Placebo	Placebo Intramuscular injection

Primary Outcome Measures

Name	Time	Method
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)	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.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States