A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

1720201

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.

2017-06-12

2018-02-20

2018-02-20

Completed

Early phase I

59

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}

2023-09-18