Phase 2 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: Completed

Administrative data

• NCT number: NCT03137407
• Other study ID #: 1720201
• Status: Completed
• Phase: Phase 2
• Start date: June 12, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: August 2023
• 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: Completed
• Enrollment: 59
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• 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

• 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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Biological:
• Botulinum Toxins, Type A
Intramuscular injection
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
United States	Weil Foot and Ankle Institute	Des Plaines	Illinois
United States	Village Podiatry Centers	Duluth	Georgia
United States	Kansas City Bone & Joint Clinic	Overland Park	Kansas
United States	Element Research Group	San Antonio	Texas
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8
Secondary	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.	Weeks 1, 2, 4, 8, and 16
Secondary	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.	Weeks 1, 2, 4, 8, and 16
Secondary	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.	Weeks 1, 2, 4, 8, and 16