A Phase 3 interventional study of DaxibotulinumtoxinA for injection and Placebo in Cervical Dystonia, sponsored by Revance Therapeutics, Inc.. Completed at 75 sites in 9 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Revance Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).
Approximately 300 subjects, recruited from approximately 80 study centers in the United States (US), Canada, and Europe will be randomized to DAXI for injection high dose, DAXI for injection low dose, or placebo group, respectively. Subjects will be stratified by treatment center and history of prior treatment with botulinum neurotoxin (BoNT).
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's enrollment of 301 is above the median of 32 across 181 interventional studies indexed under Dystonia.
Browse Dystonia studies →Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low Dose Group
Biological: DaxibotulinumtoxinA for injection
High Dose Group
Biological: DaxibotulinumtoxinA for injection
Placebo Group
Biological: Placebo
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 is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Change from Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-total score
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).
Time frame: Week 4 and Week 6
Change from Baseline TWSTRS-total score
Change from baseline in TWSTRS-total score (all post-treatment time points)
Time frame: Up to 36 Weeks
Duration of effect
Duration of effect based on target TWSTRS score
Time frame: Up to 36 Weeks
Patient Global Impression of Change (PGIC) Improvement
Percentage responders at Week 4 or 6
Time frame: Week 4 or Week 6
Incidence of treatment-emergent adverse events (Safety)
Evaluation of adverse events and serious adverse events over the course of the study.
Time frame: Up to 36 Weeks
Change in TWSTRS subscale scores
Change from baseline in TWSTRS subscale scores (TWSTRS-Severity, TWSTRS-Disability, and TWSTRS-Pain) (all post-treatment time points)
Time frame: Up to 36 Weeks
Clinical Global Impression of Change (CGIC)
CGIC at all post-treatment time points
Time frame: Up to 36 Weeks
Patient Global Impression of Change (PGIC)
PGIC at all post-treatment time points
Time frame: Up to 36 Weeks
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Revance Therapeutics, Inc.