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Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

This study is currently recruiting participants.
Verified August 2017 by Revance Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03137407
First Posted: May 2, 2017
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Plantar Fasciitis Biological: Botulinum Toxins, Type A Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Further study details as provided by Revance Therapeutics, Inc.:

Primary Outcome Measures:
  • Reduction in the visual analog scale (VAS) for pain for the foot [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Reduction in VAS for pain for the foot [ Time Frame: Up to 16 weeks ]
  • American Orthopaedic Foot and Ankle Score (AOFAS) [ Time Frame: Up to 16 weeks ]
  • Patient Reported Outcomes [ Time Frame: Up to 16 weeks ]

Estimated Enrollment: 60
Actual Study Start Date: June 12, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DaxibotulinumtoxinA 240 units
Botulinum Toxins, Type A Intramuscular Injection
Biological: Botulinum Toxins, Type A
Intramuscular injection
Other Name: DaxibotulinumtoxinA
Placebo Comparator: Placebo
Placebo Intramuscular Injection
Biological: Placebo
Intramuscular injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137407


Contacts
Contact: Jaidyn Nguyen 510-742-3400 jnguyen@revance.com

Locations
United States, Georgia
Village Podiatry Centers Recruiting
Duluth, Georgia, United States, 30096
United States, Illinois
Weil Foot and Ankle Institute Recruiting
Des Plaines, Illinois, United States, 60016
United States, Kansas
Kansas City Bone & Joint Clinic Recruiting
Overland Park, Kansas, United States, 66211
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Element Research Group Recruiting
San Antonio, Texas, United States, 78212
Sponsors and Collaborators
Revance Therapeutics, Inc.
  More Information

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03137407     History of Changes
Other Study ID Numbers: 1720201
First Submitted: April 27, 2017
First Posted: May 2, 2017
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Revance Therapeutics, Inc.:
heel pain

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents