Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

Last updated: November 29, 2022
Sponsor: Revance Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Neck Pain

Dystonias

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT03608397
1720302
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, 18 to 80 years of age
  • Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized tothe head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1),defined as a TWSTRS-total score of at least 20, with at least 15 on theTWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1on the TWSTRS-Pain subscale

Exclusion

Exclusion Criteria:

  • Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollisor tardive torticollis)
  • Predominant retrocollis or anterocollis CD
  • Significant dystonia in other body areas, or is currently being treated with BoNT fordystonia in areas other than those associated with isolated CD
  • Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening orBaseline (prior to study treatment)
  • Any neuromuscular neurological conditions that may place the subject at increased riskof morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscularjunctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
  • Previous treatment with any BoNT product for any condition within the 14 weeks priorto Screening
  • Botulinum Neurotoxin Type A (BoNTA), except the investigational daxibotulinumtoxinA,treatment-experienced subjects who had suboptimal or no treatment response to the mostrecent BoNTA injection for CD, as determined by the investigator, or history ofprimary or secondary non-response to BoNTA injections, known to have neutralizingantibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinB [Myobloc/Neurobloc]) injection for CD due to non-response or suboptimal response toBoNTA

Study Design

Total Participants: 301
Study Start date:
June 20, 2018
Estimated Completion Date:
June 16, 2020

Study 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).

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Universitaetsklinik fuer Neurologie

    Wien, 1090
    Austria

    Site Not Available

  • University Health Network, Toronto Western Hospital

    Toronto, Ontario M5T2S8
    Canada

    Site Not Available

  • Fakultni nemocnice Olomouc, Neurologicka klinika

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Fakultní nemocnice Ostrava, Neurologicka klinika

    Ostrava-Poruba, 70852
    Czechia

    Site Not Available

  • Lekarna Pardubicke nemocnice

    Pardubice, 53203
    Czechia

    Site Not Available

  • Neurologicka klinika 1. LF UK a VFN v Praze

    Praha, 12821
    Czechia

    Site Not Available

  • Vestra Clinics s.r.o.

    Rychnov Nad Kněžnou, 51601
    Czechia

    Site Not Available

  • Hôpital Neurologique Pierre Wertheimer

    Bron, 69500
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble cedex 09, 38043
    France

    Site Not Available

  • Hôpital Roger Salengro - CHRU de Lille

    Lille, 59037
    France

    Site Not Available

  • CHU Caremeau, Service de Neurologie

    Nimes cedex 09, 30029
    France

    Site Not Available

  • Praxis fuer Neurologie im Bismark Karrée

    Berlin, 10627
    Germany

    Site Not Available

  • Universitaetsklinikum Duesseldorf

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TUM

    Muenchen, 81675
    Germany

    Site Not Available

  • GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

    Troisdorf, 53844
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

    Gdansk, 80462
    Poland

    Site Not Available

  • Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

    Krakow, 30539
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii

    Kraków, 31505
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01868
    Poland

    Site Not Available

  • Mazowiecki Szpital Brodnowski Sp. z o.o.

    Warszaw, 03-242
    Poland

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Burgos

    Burgos, 09006
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Royal Devon and Exeter Foundation Trust Hospital

    Exeter, EX25DW
    United Kingdom

    Site Not Available

  • The Walton Centre NHS Foundation Trust

    Liverpool, L97LJ
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, M55AP
    United Kingdom

    Site Not Available

  • HOPE Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona 85258-4581
    United States

    Site Not Available

  • The Parkinsons and Movement Disorder Institute

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

  • USC Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • Care Access Research

    Pasadena, California 91101
    United States

    Site Not Available

  • Sutter Institute for Medical Research

    Sacramento, California 95816
    United States

    Site Not Available

  • Rocky Mountain Movement Disorders Center

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Associated Neurologist, P.C.

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Design Neuroscience Center

    Doral, Florida 33172
    United States

    Site Not Available

  • University of Florida Center for Movement Disorders and Neurorestoration

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Infinity Clinical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • University of Florida Health Science Center Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Suncoast Neuroscience Associates

    Saint Petersburg, Florida 33713-8844
    United States

    Site Not Available

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida 33613
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Kansas Institute of Reseach

    Overland Park, Kansas 66211-1358
    United States

    Site Not Available

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • QUEST Research Institute

    Farmington, Michigan 48334
    United States

    Site Not Available

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • St Louis University

    Saint Louis, Missouri 63105
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Mount Sinai Movement Disorders Center

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14618
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania, Department of Neurology

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Coastal Neurology

    Port Royal, South Carolina 29935
    United States

    Site Not Available

  • Wesley Neurology Clinic

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Neurology. P.A.

    Dallas, Texas 37232
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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