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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03617367 | Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) | PHASE3 | COMPLETED | 357 | — | — | Sep 5, 2018 | May 25, 2021 | Jan 28, 2022 | 65 | United States, Austria +7 |
| NCT03608397 | Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1) | PHASE3 | COMPLETED | 301 | — | — | Jun 20, 2018 | Jun 16, 2020 | Dec 5, 2022 | 75 | United States, Austria +7 |
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).
| 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 |
| 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. |
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...