DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.

Detailed Description
-----------------
Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.

Official Title
-----------------
A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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

Intervention / Treatment
-----------------
* Biological: DAXI 80 U
* Biological: DAXI 120 U
* Other: 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 unilateral plantar fasciitis. Persistent heel pain. Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study. Exclusion Criteria: Previous injection of botulinum toxin in the lower extremities or feet. Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation. Pregnant, nursing, or 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. Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.

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
Interventional Model Description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAXI 80 U<br>LOW Dose Group | Biological: DAXI 80 U<br>* DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)<br>|
| Experimental: DAXI 120 U<br>HIGH Dose Group | Biological: DAXI 120 U<br>* DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)<br>|
| Placebo Comparator: Placebo<br>Placebo Group. | Other: Placebo<br>* Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Week 8 in Foot Function Index (FFI) | The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100. | Week 8 | 
| Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | For the proportion of subjects with a decrease from baseline of >= 20% in NPRS score at Week 8 | Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA