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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03821402 | Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity | PHASE2 | COMPLETED | 83 | — | — | Dec 12, 2018 | Nov 23, 2020 | Sep 21, 2023 | 26 | United States |
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Mean score on the Physician Global Impression of Change (PGIC) score at week 6. The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved).
| Arm | Type | Description |
|---|---|---|
| DAXI 250 U | EXPERIMENTAL | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose |
| DAXI 375 U | EXPERIMENTAL | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U |
| DAXI 500 U | EXPERIMENTAL | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U |
| Placebo | PLACEBO_COMPARATOR | Placebo group |
| Name | Type | Description |
|---|---|---|
| DAXI for injection 250 U | BIOLOGICAL | DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline |
| DAXI for injection 375 U | BIOLOGICAL | DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline. |
| DAXI for injection 500 U | BIOLOGICAL | DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline |
| 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: * 18 to 75 years of age * Written informed consent including authorization to release health information * Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or traumatic brain injury (TBI), last stroke or TBI \> 24 weeks prior to Screening * ULS with ...