Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

NCT03617367 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 357 participants
Start Date 2018-09-05
Est. Completion 2021-05-25
Phase Phase 3

Sponsor

Revance Therapeutics

9 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03617367

The ClinicalTrials.gov registry entry for NCT03617367 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Revance Therapeutics, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03617367 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03617367?

The interventions under investigation include: daxibotulinumtoxinA for injection (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03617367?

This trial is sponsored by Revance Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial