DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02973269
• Other study ID #: RT002-CL008
• Status: Terminated
• Phase: Phase 2
• Start date: November 14, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: March 2024
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Biological:
• daxibotulinumtoxin type A
Intramuscular injection
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)	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.	16 weeks