Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

NCT03137407 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 1720201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 5

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.

Conditions

Plantar Fasciitis

Keywords

heel pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16

  Weeks 1, 2, 4, 8, and 16

• Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)

  Weeks 1, 2, 4, 8, and 16

• Change From Baseline Through Week 16 for the Foot and Ankle Disability Index

  Weeks 1, 2, 4, 8, and 16

Study Arms (2)

DAXI 240 U

EXPERIMENTAL

DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U

Biological: Botulinum Toxins, Type A

Placebo

PLACEBO COMPARATOR

Placebo Intramuscular Injection

Biological: Placebo

Interventions

Botulinum Toxins, Type A BIOLOGICAL

Intramuscular injection

Also known as: DaxibotulinumtoxinA

DAXI 240 U

Placebo BIOLOGICAL

Intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (5)

Village Podiatry Centers

Duluth, Georgia, 30096, United States

Location

Weil Foot and Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

Kansas City Bone & Joint Clinic

Overland Park, Kansas, 66211, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Element Research Group

San Antonio, Texas, 78212, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Todd Gross, PhD, VP, Clinical Development & Data Science
• Organization: Revance Therapeutics, Inc.

tgross@revance.com

510-742-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: June 12, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: September 18, 2023
• Results First Posted: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)