Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Study Overview
=================
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.

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

Conditions
-----------------
Plantar Fasciitis

Intervention / Treatment
-----------------
* Biological: Botulinum Toxins, Type A
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAXI 240 U<br>DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U | Biological: Botulinum Toxins, Type A<br>* Intramuscular injection<br>* Other names: DaxibotulinumtoxinA;|
| Placebo Comparator: Placebo<br>Placebo Intramuscular Injection | Biological: Placebo<br>* Intramuscular injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heel pain