Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03617367 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
A Phase 3 study of Cervical Dystonia, sponsored by Revance Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT03617367: Completed Phase 3 study of Cervical Dystonia, sponsored by Revance Therapeutics.
NCT03617367 is a Phase 3 study of Cervical Dystonia that has completed, run by Revance Therapeutics. The registered enrollment target is 357 participants, above the 63-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (467% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617367, a Phase 3 study of Cervical Dystonia, has completed, sponsored by Revance Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.
Primary Outcome
Evaluation of adverse events and serious adverse events, from multiple continuous treatments of DAXI for injection, over the course of the study.
Conditions Studied
Interventions
- BIOLOGICAL daxibotulinumtoxinA for injection
Study Locations (20)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- University of Florida Center for Movement Disorders and Neurorestoration - Gainesville
- Infinity Clinical research - Hollywood
- University of Miami - Miami
- Suncoast Neuroscience Associates - St. Petersburg
- USF Parkinson's Disease and Movement Disorders Center - Tampa
California
- The Parkinsons and Movement Disorder Institute - Fountain Valley
- Loma Linda University - Loma Linda
- USC Keck School of Medicine - Los Angeles
- Care Access Research LLC - Pasadena
Michigan
- Michigan State University - East Lansing
- QUEST Research Institute - Farmington
- Henry Ford West Bloomfield Hospital - West Bloomfield
Arizona
- HOPE Research Institute - Phoenix
- Movement Disorders Center of Arizona - Scottsdale
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
Connecticut
- Ki Health Partners LLC DBA New England Institute for Clinical Research - Stamford
Georgia
- Emory University - Atlanta
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 3 |
What the finished NCT03617367 record still lists
NCT03617367 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (467% higher).
The record links to 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 1 intervention - of which daxibotulinumtoxinA for injection is the first listed.
NCT03617367 names 20 study sites across 9 states, led by Florida, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT03617367 about?
NCT03617367 is a clinical study titled "Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)". Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.
What is the current status of trial NCT03617367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 357 participants. The study started on 2018-09-05. Estimated completion is 2021-05-25.
What conditions does trial NCT03617367 study?
This clinical trial studies the following conditions: Cervical Dystonia.
What interventions are being tested in trial NCT03617367?
The interventions under investigation include: daxibotulinumtoxinA for injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT03617367?
This trial is sponsored by Revance Therapeutics, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03617367 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Dystonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03617367's enrollment target sits among peer trials
357 1st of 15 higher than 15 of 15 other Cervical Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Dystonia 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
-
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
COMPLETED · Phase 3
-
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
COMPLETED · Phase 3
-
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults
RECRUITING · Phase 2
-
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
RECRUITING · Phase 2
-
Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
RECRUITING · NA
-
Zinc as an Adjunctive Therapy for Cervical Dystonia
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06062888 · 357 participants · Phase 2
FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
- NCT06109766 · 357 participants · NA
Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth
- NCT06231342 · 357 participants · NA
Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
- NCT06533826 · 357 participants · Phase 2
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI