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DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825315
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Biological: DAXI for Injection: LOW Dose Other: DAXI for Injection: HIGH Dose Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blinded
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: DAXI for Injection: LOW Dose
LOW Dose Group
Biological: DAXI for Injection: LOW Dose
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.

Experimental: DAXI for Injection: HIGH Dose
HIGH Dose Group
Other: DAXI for Injection: HIGH Dose
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.

Placebo Comparator: Placebo
Placebo Group.
Other: Placebo
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.




Primary Outcome Measures :
  1. Change from baseline in the Numeric Pain Rating Scale (NPRS) score [ Time Frame: Week 8 ]
    Change from baseline in the Numeric Pain Rating Scale (NPRS) score (Scale Range: 0 {No pain} to 10 {Worst pain imaginable})


Secondary Outcome Measures :
  1. Change from baseline in Foot Function Index (FFI) [ Time Frame: All post treatment time points (approximately 6 months) ]
    Change from baseline in Foot Function Index (FFI) (Pain Sub-Scale Range: 0 {No pain} to 10 {Worst pain imaginable}, Disability Sub-Scale Range: 0 {No difficulty} to 10 {So difficult unable to do so}, Activity Limitation Sub-Scale Range: 0 {None of the time} to 10 {All of the time})


Other Outcome Measures:
  1. Moderate improvement on the Clinical Global Impression of Change (CGIC) [ Time Frame: All post treatment time points (approximately 6 months) ]
    Proportion of subjects with improvement on the Clinical Global Impression of Change (CGIC) over time

  2. Improvement on the the Patient Global Impression of Change (PGIC) [ Time Frame: All post treatment time points (approximately 6 months) ]
    Proportion of subjects with improvement on the Patient Global Impression of Change (PGIC) over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 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.

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): NCT03825315


Locations
Show Show 21 study locations
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
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Study Director: Roman Rubio, MD Revance Therapeutics, Inc.
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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03825315    
Other Study ID Numbers: 1820201
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revance Therapeutics, Inc.:
DAXI for injection,
Plantar Fasciitis,
Heel Pain,
BotulinumtoxinA
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases