Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03825315 | DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis | PHASE2 | COMPLETED | 155 | — | — | Dec 31, 2018 | Jun 4, 2020 | Sep 21, 2023 | 20 | United States |
Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
| Arm | Type | Description |
|---|---|---|
| DAXI 80 U | EXPERIMENTAL | LOW Dose Group |
| DAXI 120 U | EXPERIMENTAL | HIGH Dose Group |
| Placebo | PLACEBO_COMPARATOR | Placebo Group. |
| Name | Type | Description |
|---|---|---|
| DAXI 80 U | BIOLOGICAL | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) |
| DAXI 120 U | BIOLOGICAL | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group) |
| Placebo | OTHER | 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. |
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 Sc...