Phase 2 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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-02-20

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

Botulinum Toxins, 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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Botulinum Toxins, Type A

Intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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DaxibotulinumtoxinA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No