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Also known as DAXI for injection 250 U
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 an investigational formulation of daxibotulinumtoxinA for injection developed by Revance Therapeutics, Inc. (RVNC). It is being studied as a treatment for upper limb spasticity in adults, a neurological condition involving involuntary muscle tightness. DAXI 250 U has completed a Phase 2 clinical trial and is not yet approved.
DAXI 250 U is being developed for the treatment of upper limb spasticity in adults. Upper limb spasticity is a neurological condition characterized by increased muscle tone in the arms. The investigational therapy has been evaluated in a completed Phase 2 trial in this indication and is not approved for any use.
DAXI 250 U is developed by Revance Therapeutics, Inc., which trades under the ticker RVNC. The company is studying the injectable formulation for upper limb spasticity in adults. Revance Therapeutics is the sponsor of the clinical program for this asset.
DAXI 250 U is in Phase 2 development. It has completed one Phase 2 clinical trial in adult upper limb spasticity. The drug is investigational and has not been approved by the FDA for any indication.
DAXI 250 U has been studied in one completed Phase 2 trial, NCT03821402, titled Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity. The trial enrolled 83 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.
Yes, DAXI 250 U is also known as DAXI for injection 250 U. Both names refer to the same investigational daxibotulinumtoxinA formulation developed by Revance Therapeutics, Inc. (RVNC) for upper limb spasticity. The alternative name reflects the injectable form and the 250-unit strength.