Trials / Completed
CompletedNCT03608397
Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- Revance Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DaxibotulinumtoxinA for injection | 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. |
| BIOLOGICAL | Placebo | 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. |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2019-12-03
- Completion
- 2020-06-16
- First posted
- 2018-08-01
- Last updated
- 2022-12-05
Locations
75 sites across 9 countries: United States, Austria, Canada, Czechia, France, Germany, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03608397. Inclusion in this directory is not an endorsement.