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

PHASE3CompletedINTERVENTIONAL
Enrollment

357

Participants

Timeline

Start Date

September 5, 2018

Primary Completion Date

May 25, 2021

Study Completion Date

May 25, 2021

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.

Trial Locations (65)

10029

Mount Sinai Movement Disorders Center, New York

10561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn

12821

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

14618

University of Rochester, Rochester

19107

University of Pennsylvania, Philadelphia

27157

Wake Forest Health Sciences, Winston-Salem

27710

Duke University, Durham

28006

Hospital Universitario de La Princesa, Madrid

29935

Coastal Neurology, Port Royal

30029

CHU Caremeau, Nîmes

30322

Emory University, Atlanta

30539

Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck, Innsbruck

Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny, Krakow

30625

Medizinische Hochschule Hannover, Hanover

31505

Krakowska Akademia Neurologii Sp. z o.o., Krakow

32609

University of Florida Center for Movement Disorders and Neurorestoration, Gainesville

33024

Infinity Clinical research, Hollywood

33136

University of Miami, Miami

33486

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

33613

USF Parkinson's Disease and Movement Disorders Center, Tampa

33713

Suncoast Neuroscience Associates, St. Petersburg

37232

Vanderbilt University Medical Center, Nashville

38018

Intrafusion Research Network - Wesley Neurology Clinic, Cordova

38043

CHU de Grenoble, Grenoble

38157

Veracity Neuroscience LLC, Memphis

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

Nemocnice Pardubickeho kraje, a.s.; Pardubicka nemocnice, Pardubice

53844

GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar, Troisdorf

59037

Hôpital Roger Salengro, Lille

60612

Rush University Medical Center, Chicago

63104

St Louis University, St Louis

63110

Washington University, St Louis

68105

University of Nebraska Medical Center, Omaha

69500

Hôpital Neurologique Pierre Wertheimer, Bron

70852

Fakultní nemocnice Ostrava, Ostrava-Poruba

72076

Universitätsklinikum Tübingen, Tübingen

75214

Texas Neurology. P.A., Dallas

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

85258

Movement Disorders Center of Arizona, Scottsdale

90033

USC Keck School of Medicine, Los Angeles

91101

Care Access Research LLC, Pasadena

92354

Loma Linda University, Loma Linda

92708

The Parkinsons and Movement Disorder Institute, Fountain Valley

06905

Ki Health Partners LLC DBA New England Institute for Clinical Research, Stamford

66211-1358

Kansas Institute of Research, Overland Park

05401

The University of Vermont Medical Center, Burlington

M5T 2S8

University Health Network, Toronto Western Hospital, Toronto

01868

Centrum Medyczne Pratia Warszawa, Warsaw

03242

Mazovian Brodno Hospital, Warsaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

09006

Hospital Universitario Burgos, Burgos

EX2 5DW

Royal Devon and Exeter Foundation Trust Hospital, Exeter

L97LJ

The Walton Centre NHS Foundation Trust, Neuroscience Research Centre, Liverpool

M55AP

Salford Royal NHS Foundation Trust, Salford

Sponsors

Collaborators (1)

All Listed Sponsors
lead

Revance Therapeutics, Inc.

INDUSTRY

collaborator

Syneos Health

OTHER

NCT03617367 - Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) | Biotech Hunter | Biotech Hunter