DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Phase 2

Terminated

• Conditions: Plantar Fasciitis

• 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

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