DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Revance Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Plantar Fasciitis

Treatments: Biological: daxibotulinumtoxin type A; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02973269

RT002-CL008

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups, including a placebo group

DAXI 240 U

Experimental group

Description:

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

Treatment:

Biological: daxibotulinumtoxin type A

Placebo

Placebo Comparator group

Description:

Placebo Intramuscular injection

Treatment:

Biological: Placebo