Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAXI 250 U · 1 trial · 1 indication
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 ...
DAXI 250 U is used for the treatment of adult upper limb spasticity, a condition of increased muscle tone in the arm or hand. It is an investigational therapy being studied for this neurological indication.
DAXI 250 U is a monoclonal antibody designed to target the neuromuscular junction. It is being developed to reduce muscle spasticity by modulating nerve signals that cause excessive muscle contraction.
DAXI 250 U is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVNC.
DAXI 250 U is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for commercial use.
DAXI 250 U has one completed Phase 2 clinical trial, NCT03821402, which evaluated its efficacy and safety in 83 adult patients with upper limb spasticity in the United States. The trial was randomized, double-blind, and placebo-controlled.
DAXI 250 U is a formulation of DaxibotulinumtoxinA for injection. The clinical trial NCT03821402 specifically studied DaxibotulinumtoxinA for injection, and DAXI 250 U refers to this investigational product.