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daxibotulinumtoxinA · 6 trials · 5 indications
Evaluation of adverse events and serious adverse events, from multiple continuous treatments of DAXI for injection, over the course of the study.
TWSTRS is used to assess the severity of cervical Dystonia and the success of its treatment. The average of the change from baseline in TWSTRS-total score at Weeks 4 and 6 will be determined. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
| Arm | Type | Description |
|---|---|---|
| daxibotulinumtoxinA (DAXI) for injection | EXPERIMENTAL | DAXI for injection |
| DAXI for injection low dose | EXPERIMENTAL | Low Dose Group |
| DAXI for injection high dose | EXPERIMENTAL | High Dose Group |
| Placebo | PLACEBO_COMPARATOR | Placebo Group |
| DAXI 40 U GL / 32 U FHL / 48 U LCL | EXPERIMENTAL | DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL) |
| Cohort 1: DAXI 12 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 2: DAXI 24 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 3: DAXI 36 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 4: DAXI 48 U | EXPERIMENTAL | DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) |
| Cohort 1: Dose A | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 2: Dose B | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 3: Dose C | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Cohort 4: Dose D | EXPERIMENTAL | DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) |
| Name | Type | Description |
|---|---|---|
| daxibotulinumtoxinA for injection | 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 | BIOLOGICAL | 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. |
| DaxibotulinumtoxinA | BIOLOGICAL | Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study |
Inclusion Criteria: * Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least...
DaxibotulinumtoxinA is an investigational botulinum toxin type A product being studied for aesthetic and therapeutic uses, including frown lines, lateral canthal lines, forehead lines, upper facial lines, and cervical dystonia. It is in clinical development and has not been approved by the FDA.
DaxibotulinumtoxinA is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker RVNC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational product.
DaxibotulinumtoxinA is in Phase 2 clinical development for aesthetic indications such as frown lines and lateral canthal lines, and Phase 3 trials for cervical dystonia have been completed. It remains investigational and is not yet approved by regulatory authorities.
Completed trials include NCT03608397 (ASPEN-1) and NCT03617367 (ASPEN-OLS) for cervical dystonia, NCT03786770 for forehead lines, and NCT03911102 for lateral canthal lines. These studies enrolled a total of 658 participants across the United States, Canada, and Europe.
DaxibotulinumtoxinA is a specific investigational formulation of botulinum toxin type A developed by Revance Therapeutics. It is not the same as other commercially available botulinum toxin products, as it is designed with a proprietary peptide technology that may offer a longer duration of effect.