Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)
NCT ID: NCT03608397
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
301 participants
INTERVENTIONAL
2018-06-20
2020-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DAXI for injection low dose
Low Dose Group
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.
DAXI for injection high dose
High Dose Group
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.
Placebo
Placebo Group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the 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 the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale
Exclusion Criteria
* Predominant retrocollis or anterocollis CD
* Significant dystonia in other body areas, or is currently being treated with BoNT for dystonia in areas other than those associated with isolated CD
* Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
* Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
* Previous treatment with any BoNT product for any condition within the 14 weeks prior to Screening
* Botulinum Neurotoxin Type A (BoNTA), except the investigational daxibotulinumtoxinA, treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator, or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinB \[Myobloc/Neurobloc\]) injection for CD due to non-response or suboptimal response to BoNTA
18 Years
80 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, United States
University of California, Irvine
Irvine, California, United States
Loma Linda University
Loma Linda, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Care Access Research
Pasadena, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
Associated Neurologist, P.C.
Danbury, Connecticut, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Design Neuroscience Center
Doral, Florida, United States
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
University of Florida Health Science Center Jacksonville
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas Institute of Reseach
Overland Park, Kansas, United States
Michigan State University
East Lansing, Michigan, United States
QUEST Research Institute
Farmington, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
St Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Movement Disorders Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Coastal Neurology
Port Royal, South Carolina, United States
Wesley Neurology Clinic
Cordova, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Neurology. P.A.
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Medical University Innsbruck
Innsbruck, , Austria
Universitaetsklinik fuer Neurologie
Vienna, , Austria
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada
Fakultni nemocnice Olomouc, Neurologicka klinika
Olomouc, , Czechia
Fakultní nemocnice Ostrava, Neurologicka klinika
Ostrava-Poruba, , Czechia
Lekarna Pardubicke nemocnice
Pardubice, , Czechia
Neurologicka klinika 1. LF UK a VFN v Praze
Prague, , Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, , Czechia
Hôpital Neurologique Pierre Wertheimer
Bron, , France
CHU Grenoble Alpes
Grenoble, , France
Hôpital Roger Salengro - CHRU de Lille
Lille, , France
CHU Caremeau, Service de Neurologie
Nîmes, , France
Praxis fuer Neurologie im Bismark Karrée
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum rechts der Isar der TUM
München, , Germany
GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar
Troisdorf, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.
Gdansk, , Poland
Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny
Krakow, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, , Poland
Centrum Medyczne Pratia Warszawa
Warsaw, , Poland
Mazowiecki Szpital Brodnowski Sp. z o.o.
Warsaw, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Burgos
Burgos, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Royal Devon and Exeter Foundation Trust Hospital
Exeter, , United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Countries
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References
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Comella CL, Jankovic J, Hauser RA, Patel AT, Banach MD, Ehler E, Vitarella D, Rubio RG, Gross TM; ASPEN-1 Study Group. Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial. Neurology. 2024 Feb 27;102(4):e208091. doi: 10.1212/WNL.0000000000208091. Epub 2024 Jan 31.
Other Identifiers
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1720302
Identifier Type: -
Identifier Source: org_study_id
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