Trial · NCT03608397
Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
NCT03608397, Phase 3, Completed, Revance Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1). Trials, record NCT03608397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03608397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
- NCT number
- NCT03608397
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- Revance Therapeutics, Inc.
- Conditions
- Cervical Dystonia
- Interventions
- DaxibotulinumtoxinA for injection, Placebo
- First posted
- 2018-08-01
- Last updated
- 2022-12-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-total score | Week 4 and Week 6 | 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). |
| Secondary | Change from Baseline TWSTRS-total score | Up to 36 Weeks | Change from baseline in TWSTRS-total score (all post-treatment time points) |
| Secondary | Duration of effect | Up to 36 Weeks | Duration of effect based on target TWSTRS score |
| Secondary | Patient Global Impression of Change (PGIC) Improvement | Week 4 or Week 6 | Percentage responders at Week 4 or 6 |
| Secondary | Incidence of treatment-emergent adverse events (Safety) | Up to 36 Weeks | Evaluation of adverse events and serious adverse events over the course of the study. |
| Other | Change in TWSTRS subscale scores | Up to 36 Weeks | Change from baseline in TWSTRS subscale scores (TWSTRS-Severity, TWSTRS-Disability, and TWSTRS-Pain) (all post-treatment time points) |
| Other | Clinical Global Impression of Change (CGIC) | Up to 36 Weeks | CGIC at all post-treatment time points |
| Other | Patient Global Impression of Change (PGIC) | Up to 36 Weeks | PGIC at all post-treatment time points |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38295339 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03608397
GET https://conductscience.org/api/trials/v1/NCT03608397/registered