Clinical trial NCT03825315: DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Official title: A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plantar Fasciitis
Keywords: DAXI for injection,
Plantar Fasciitis,
Heel Pain,
BotulinumtoxinA
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline at Week 8 in Foot Function Index (FFI)
timeFrame: Week 8
measure: Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS
timeFrame: Week 8
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Aung Foot Health Clinic
state: Arizona
city: Carmichael
country: United States
facility: Sacramento Foot and Ankle Center, Inc
state: California
city: Castro Valley
country: United States
facility: Bay Area Foot Care
state: California
city: Huntington Beach
country: United States
facility: West Coast Foot and Ankle
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: San Francisco
country: United States
facility: Bay Area Foot Care
state: California
city: Santa Monica
country: United States
facility: University Foot and Ankle Foundation
state: California
city: West Palm Beach
country: United States
facility: LA Podiatry Group
state: Florida
city: Belleville
country: United States
facility: Podiatry 1st
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University of Medicine & Science
state: Illinois
city: Overland Park
country: United States
facility: Kansas Institute of Research
state: Kansas
city: Las Vegas
country: United States
facility: Advanced Foot & Ankle Center
state: Nevada
city: Oklahoma City
country: United States
facility: Medical Research International
state: Oklahoma
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Houston
country: United States
facility: Hermann Drive Research Hospital
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Strash Foot and Ankle Care
state: Texas
city: San Antonio
country: United States
facility: The Podiatry Group of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Foot and Ankle, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
References: