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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 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.

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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.

Conditions Studied

Cervical Dystonia

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

27 total trials

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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, categorized as Phase 3. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 63-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (467% higher). The listed sponsor is Revance Therapeutics, which has 27 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.