DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DAXI 240 U

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

Group Type EXPERIMENTAL

daxibotulinumtoxin type A

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Placebo Intramuscular injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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daxibotulinumtoxin type A

Intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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DAXI

Eligibility Criteria

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Inclusion Criteria

* Written informed consent, including authorization to release health information
* Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at Screening Visit 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No