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Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT03137407
Recruitment Status : Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Biological: Botulinum Toxins, Type A Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
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



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

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


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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

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


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

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03137407     History of Changes
Other Study ID Numbers: 1720201
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 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