AzTrials
AzTrials

Cervical DystoniaPhase 3ASPEN-OLSNCT03617367

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

A Phase 3 study testing daxibotulinumtoxinA for injection in people with Cervical Dystonia, run by Revance Therapeutics, Inc. at 65 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cervical Dystonia
What is being tested?
daxibotulinumtoxinA for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
357 participants
Where
65 sitesin 9 countries
Study dates
5 Sep 2018to 25 May 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (minimum TWSTRS subscale criteria applicable only to subjects not previously enrolled in Study Protocol 1720302)
  • Subjects who were previously enrolled in Study Protocol 1720302, and completed the study, including:
  • Those with no reduction or have an increase from baseline in the average TWSTRS-total score at Weeks 4 and 6 (i.e., no improvement or worsened disease status), and the investigator agreed that there was a need for retreatment based on the subject's symptoms and neurologic exam findings
  • Those who benefited from study treatment and completed follow-up study visits up to the time point of when their TWSTRS - total score reached/exceeded their target TWSTRS score
  • Those who benefited from study treatment but subsequently experienced significant recurrence of CD symptoms (e.g. pain) during the study before their TWSTRS-total score reached their target TWSTRS score and requested retreatment, which the investigator determined was warranted based on the subject's symptoms and neurologic exam findings
  • Those who completed study visits up to Week 36 and their TWSTRS-total score never reached their target TWSTRS score and they never requested another treatment. The investigator determined that these subjects can be followed in the OLS until their TWSTRS-total score is the same or higher than their target TWSTRS score or until they request retreatment, which the investigator determined is clinically indicated
Show all 9Show fewer
  • De novo subjects (not previously enrolled in Study Protocol 1720302):
  • Naïve to BoNT treatment
  • BoNT treatment-experienced; if previously treated with BoNTA, the subject must have demonstrated a clinically meaningful response to the last BoNTA treatment based on the clinical judgment of the investigator

Who cannot join

  • Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
  • Predominant retrocollis or anterocollis CD
  • Significant dystonia in other body areas, or is currently being treated with botulinum toxin (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 (applicable only to de novo subjects)
  • Botulinum neurotoxin 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 (rimabotulinumtoxinA [Myobloc/Neurobloc]) injection for CD due to non-response or suboptimal response to BoNTA (applicable only to de novo subjects)

Trial locations and contacts

65 sites in 9 countries.

65 sites in 9 countries

United States37 sites

  • Emory University

    Atlanta, Georgia, 30322

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

    Boca Raton, Florida, 33486

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Intrafusion Research Network - Wesley Neurology Clinic

    Cordova, Tennessee, 38018

  • Texas Neurology. P.A.

    Dallas, Texas, 75214

  • Duke University

    Durham, North Carolina, 27710

  • Michigan State University

    East Lansing, Michigan, 48824

  • Rocky Mountain Movement Disorders Center

    Englewood, Colorado, 80113

  • QUEST Research Institute

    Farmington, Michigan, 48334

  • The Parkinsons and Movement Disorder Institute

    Fountain Valley, California, 92708

  • University of Florida Center for Movement Disorders and Neurorestoration

    Gainesville, Florida, 32609

  • Infinity Clinical research

    Hollywood, Florida, 33024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Loma Linda University

    Loma Linda, California, 92354

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Veracity Neuroscience LLC

    Memphis, Tennessee, 38157

  • University of Miami

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mount Sinai Movement Disorders Center

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Kansas Institute of Research

    Overland Park, Kansas, 66211-1358

  • Care Access Research LLC

    Pasadena, California, 91101

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • Coastal Neurology

    Port Royal, South Carolina, 29935

  • University of Rochester

    Rochester, New York, 14618

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona, 85258

  • St Louis University

    St Louis, Missouri, 63104

  • Washington University

    St Louis, Missouri, 63110

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • Ki Health Partners LLC DBA New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Poland6 sites

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

    Gdansk, 80462

  • Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

    Krakow, 30539

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow, 31505

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10561

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01868

  • Mazovian Brodno Hospital

    Warsaw, 03242

Other trials in Poland

Germany5 sites

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum rechts der Isar der TUM

    München, 81675

  • GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

    Troisdorf, 53844

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Czechia4 sites

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 70852

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

    Pardubice, 53203

  • Neurologicka klinika 1. LF UK a VFN v Praze

    Prague, 12821

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 51601

Other trials in Czechia

France4 sites

  • Hôpital Neurologique Pierre Wertheimer

    Bron, 69500

  • CHU de Grenoble

    Grenoble, 38043

  • Hôpital Roger Salengro

    Lille, 59037

  • CHU Caremeau

    Nîmes, 30029

Other trials in France

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Burgos

    Burgos, 09006

  • Hospital Universitario de La Princesa

    Madrid, 28006

Other trials in Spain

United Kingdom3 sites

  • Royal Devon and Exeter Foundation Trust Hospital

    Exeter, EX2 5DW

  • The Walton Centre NHS Foundation Trust, Neuroscience Research Centre

    Liverpool, L97LJ

  • Salford Royal NHS Foundation Trust

    Salford, M55AP

Other trials in United Kingdom

Austria1 site

  • Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck

    Innsbruck, 30539

Other trials in Austria

Canada1 site

  • University Health Network, Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Phase 3, Open-Label, Multi-Center Trial to Evaluate the 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.

Read the detailed description

Approximately 350 adult subjects will be recruited from approximately 80 study centers in the United States, Canada, and Europe who were enrolled in the ASPEN-1 Study Protocol 1720302 and de novo subjects (not previously enrolled in ASPEN-1 Study Protocol 1720302) will be treated with up to 4 different doses of daxibotulinumtoxinA for injection.

Being tested
daxibotulinumtoxinA for injection
Keywords
DAXI, Cervical Dystonia, TWSTRS, Toxin, multiple treatment
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • daxibotulinumtoxinA for injectionBiological

    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.

Study groups in NCT03617367
Study groupRoleWhat they receive
daxibotulinumtoxinA (DAXI) for injectionExperimentalDAXI for injection
Receives: Biological: daxibotulinumtoxinA for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Long Term Safety of patients determined by the incidence of treatment-emergent adverse events

    Evaluation of adverse events and serious adverse events, from multiple continuous treatments of DAXI for injection, over the course of the study.

    Measured: Up to 52 Weeks

Secondary outcomes (2)

  1. The proportion of subjects with at least moderate improvement on the Clinician Global Impression of Change (CGIC) at Weeks 4 or 6 for Treatment Cycles 1, 2, 3, and 4

    The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a 7-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and will be assessed by the investigator at the Week 4 and Week 6 visits.

    Measured: Weeks 4 and 6 of treatment cycles 1, 2, 3, and 4 (12 - 52 weeks duration each)

  2. The average of the change from Baseline in the TWSTRS Total Score at Weeks 4 and 6 for Treatment Cycles 1, 2, 3, and 4 [Time Frame: Weeks 4 and 6 of treatment cycles 1, 2, 3, and 4 (12 - 52 weeks duration each)]

    The difference in TWSTRS-Total score between the Baseline and average of Weeks 4 and 6 for each treatment cycle will be determined for each subject. The TWSTRS is an assessment scale used to measure the impact of CD on subjects. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).

    Measured: Weeks 4 and 6 of treatment cycles 1, 2, 3, and 4 (12 - 52 weeks duration each)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start5 Sep 2018
  3. Primary completion25 May 2021
  4. Study completion25 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a 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 with up to four different doses in adults with isolated cervical dystonia (CD).
Masking
None (open label)
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617367
Sponsor's protocol ID
1720304
Acronym
ASPEN-OLS
Status last verified
Jan 2022
First submitted
12 Jul 2018
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McAllister P, Patel AT, Banach M, Ellenbogen A, Slawek J, Paus S, Jinnah HA, Evidente V, Gross TM, Kazerooni R, Gallagher CJ, Hollander DA. Long-Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN-Open-Label Study. Mov Disord Clin Pract. 2025 Nov;12(11):1764-1773. doi: 10.1002/mdc3.70104. Epub 2025 May 29.

    PubMed 40439027

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing daxibotulinumtoxinA for injection in people with Cervical Dystonia, run by Revance Therapeutics, Inc. at 65 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Poland, Germany, Czechia, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long Term Safety of patients determined by the incidence of treatment-emergent adverse events (time frame: Up to 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617367, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in