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NCT03608397 · ClinicalTrials.gov registry record · Phase 3
Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
A Phase 3 study, sponsored by Revance Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
NCT03608397: Completed Phase 3 study, sponsored by Revance Therapeutics.
NCT03608397 is a Phase 3 study that has completed, run by Revance Therapeutics. The registered enrollment target is 301 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03608397, a Phase 3 study, has completed, sponsored by Revance Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
Study Summary
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).
Primary Outcome
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 th
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL DaxibotulinumtoxinA for injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2020-06-16 |
| Phase | Phase 3 |
What the finished NCT03608397 record still lists
NCT03608397 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03608397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03608397 about?
NCT03608397 is a clinical study titled "Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)". 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).
What is the current status of trial NCT03608397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2018-06-20. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT03608397?
The interventions under investigation include: Placebo (BIOLOGICAL), DaxibotulinumtoxinA for injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT03608397?
This trial is sponsored by Revance Therapeutics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03608397's enrollment target sits among peer trials
301 1121st of 2000 higher than 879 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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