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

PHASE3CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

June 20, 2018

Primary Completion Date

December 3, 2019

Study Completion Date

June 16, 2020

Conditions
Cervical Dystonia
Interventions
BIOLOGICAL

DaxibotulinumtoxinA for injection

DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.

BIOLOGICAL

Placebo

Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.

Trial Locations (75)

1090

Universitaetsklinik fuer Neurologie, Vienna

6020

Medical University Innsbruck, Innsbruck

10029

Mount Sinai Movement Disorders Center, New York

10627

Praxis fuer Neurologie im Bismark Karrée, Berlin

12821

Neurologicka klinika 1. LF UK a VFN v Praze, Prague

14618

University of Rochester, Rochester

19107

Thomas Jefferson University, Philadelphia

University of Pennsylvania, Department of Neurology, Philadelphia

20007

MedStar Georgetown University Hospital, Washington D.C.

27157

Wake Forest Health Sciences, Winston-Salem

27710

Duke University, Durham

28006

Hospital Universitario de La Princesa, Madrid

29425

Medical University of South Carolina, Charleston

29935

Coastal Neurology, Port Royal

30029

CHU Caremeau, Service de Neurologie, Nîmes

30329

Emory University, Atlanta

30539

Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny, Krakow

30625

Medizinische Hochschule Hannover, Hanover

31505

Krakowska Akademia Neurologii, Krakow

32209

University of Florida Health Science Center Jacksonville, Jacksonville

32607

University of Florida Center for Movement Disorders and Neurorestoration, Gainesville

33024

Infinity Clinical Research, Hollywood

33136

University of Miami, Miami

33172

Design Neuroscience Center, Doral

33486

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

33613

USF Parkinson's Disease and Movement Disorders Center, Tampa

37232

Vanderbilt University Medical Center, Nashville

Texas Neurology. P.A., Dallas

38018

Wesley Neurology Clinic, Cordova

38043

CHU Grenoble Alpes, Grenoble

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

QUEST Research Institute, Farmington

48824

Michigan State University, East Lansing

51601

Vestra Clinics s.r.o., Rychnov nad Kněžnou

53203

Lekarna Pardubicke nemocnice, Pardubice

53844

GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar, Troisdorf

59037

Hôpital Roger Salengro - CHRU de Lille, Lille

60612

Rush University Medical Center, Chicago

63105

St Louis University, St Louis

63110

Washington University, St Louis

68198

University of Nebraska Medical Center, Omaha

69500

Hôpital Neurologique Pierre Wertheimer, Bron

70852

Fakultní nemocnice Ostrava, Neurologicka klinika, Ostrava-Poruba

72076

Universitätsklinikum Tübingen, Tübingen

77030

Baylor College of Medicine, Houston

Houston Methodist Neurological Institute, Houston

78681

Central Texas Neurology Consultants, Round Rock

80113

Rocky Mountain Movement Disorders Center, Englewood

80462

Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o., Gdansk

81675

Klinikum rechts der Isar der TUM, München

85018

HOPE Research Institute, Phoenix

90033

USC Keck School of Medicine, Los Angeles

91101

Care Access Research, Pasadena

92354

Loma Linda University, Loma Linda

92697

University of California, Irvine, Irvine

92708

The Parkinsons and Movement Disorder Institute, Fountain Valley

95816

Sutter Institute for Medical Research, Sacramento

85258-4581

Movement Disorders Center of Arizona, Scottsdale

06810

Associated Neurologist, P.C., Danbury

06905

New England Institute for Clinical Research, Stamford

33713-8844

Suncoast Neuroscience Associates, St. Petersburg

66211-1358

Kansas Institute of Reseach, Overland Park

05401

University of Vermont Medical Center, Burlington

M5T2S8

University Health Network, Toronto Western Hospital, Toronto

779 00

Fakultni nemocnice Olomouc, Neurologicka klinika, Olomouc

10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn

01868

Centrum Medyczne Pratia Warszawa, Warsaw

03-242

Mazowiecki Szpital Brodnowski Sp. z o.o., Warsaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

09006

Hospital Universitario Burgos, Burgos

EX25DW

Royal Devon and Exeter Foundation Trust Hospital, Exeter

L97LJ

The Walton Centre NHS Foundation Trust, Liverpool

M55AP

Salford Royal NHS Foundation Trust, Salford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Revance Therapeutics, Inc.

INDUSTRY