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CompletedNCT01930786ASPIREUpdated Feb 11, 2019

An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

An observational study in Muscle Spasticity, sponsored by Allergan. Completed at 55 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-11.

Sponsored by Allergan · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
744
Ages
18 Years and older
Sex
All
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Study summary

This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

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Conditions studied

  • Muscle Spasticity

Browse trials for

03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 744 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Muscle Spasticity

Inclusion criteria

  • Treatment with onabotulinumtoxinA according to the decision of the physician for spasticity
  • Willingness to complete study questionnaires and answer study questions by phone or internet

Exclusion criteria

Exclusion Criteria:

  • Concurrent participation in a clinical trial for spasticity
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
744 participants (actual)
Patient registry
No

Groups and cohorts

  • onabotulinumtoxinA

    onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.

    Drug: onabotulinumtoxinA

Interventions

  • DrugonabotulinumtoxinA

    onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.

    Also known as: BOTOX®, botulinum toxin Type A

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What researchers measure

Primary outcomes

  1. Percentage of Patients Reporting Satisfaction with Treatment

    Time frame: 5 Weeks

  2. Percentage of Health Care Providers Reporting Satisfaction with Treatment

    Time frame: 12 Weeks

Secondary outcomes

  1. Physical Functioning on a 5-Point Scale

    Time frame: 5 Weeks

  2. Severity of Pain on an 11-Point Scale

    Time frame: 5 Weeks

  3. Disability Assessment on a 4-Point Scale

    Time frame: 12 Weeks

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Study locations

55 sites
  • Loma Linda University School Of Medicine
    Loma Linda, California 92350, United States
  • MS Center of California
    Newport Beach, California 92663, United States
  • Sutter Health General Hospital
    Sacramento, California 95816, United States
  • Design Neuroscience Center
    Doral, Florida 33172, United States
  • Brooks Rehabilitation Hospital
    Jacksonville, Florida 32216, United States
  • Emerald Coast Center for Neurological Disorders
    Pensacola, Florida 32514, United States
  • Gil, Ramon A.
    Port Charlotte, Florida 33952, United States
  • Kernan Hospital
    Baltimore, Maryland 21207, United States
  • MedTechnical, PLLC
    Silver Spring, Maryland 20910, United States
  • Michigan Institute for Neurological Disorders
    Farmington Hills, Michigan 48334, United States
  • The Curators of the University of Missouri on behalf of University of Missouri Health Care
    Columbia, Missouri 65212, United States
  • Seacoast Physiatry
    Exeter, New Hampshire 03833, United States
  • CentraState Medical Center
    Freehold, New Jersey 07728, United States
  • Guilford Neurologic Associates
    Greensboro, North Carolina 27405, United States
  • Dayton Center for Neurological Disorders
    Dayton, Ohio 45459, United States
  • Albert Einstein Healthcare Network, Moss Rehabilitation Hospital
    Elkins Park, Pennsylvania 19027, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Penn Medicine Rittenhouse
    Philadelphia, Pennsylvania 19146, United States
  • University of Pittsburgh Medical Center Health System
    Pittsburgh, Pennsylvania 15213, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Metrolina Neurological Assoc., PA
    Rock Hill, South Carolina 29732, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Memorial Hermann Hospital
    Houston, Texas 77030, United States
  • Scott & White Memorial Hospital
    Temple, Texas 76508, United States
  • Swedish Neuroscience Institute
    Seattle, Washington 98122, United States
  • Center for Neurological Disorders, S.C.
    Milwaukee, Wisconsin 53215, United States
  • Hôpital Morvan
    Brest cedex 2, Finistere 239609, France
  • Pôle Saint Helier
    Rennes cedex, Ille Et Vilaine 35043, France
  • CHU de Grenoble - Hôpital Sud
    Echirolles cedex, Isere 38434, France
  • Hopital Saint Philibert - GHICL Lille
    Lomme Cedex, Nord 59160, France
  • Centre Hospitalier de Pau
    Pau cedex, Pyrenees Atlantiques 64046, France
  • Universitaetsklinikum Freiburg
    Freiburg, Baden Wuerttemberg 79106, Germany
  • Medizinische Hochschule Hannover
    Hannover, Niedersachsen 30625, Germany
  • Universitaetsklinikum Muenster
    Muenster, Nordrhein Westfalen 48149, Germany
  • Universitaetsklinikum Leipzig AoeR
    Leipzig, Sachsen 04103, Germany
  • Universitaetsklinikum Jena
    Jena, Thueringen 07740, Germany
  • Parkinson Klinik Wolfach GmbH & Co KG
    Baden Wuerttemberg, 77709, Germany
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
    Bari, 70124, Italy
  • Ospedale San Raffaele
    Milano, 20132, Italy
  • Azienda Ospedaliero - Universitaria Maggiore delle Carità
    Novara, 28100, Italy
  • Policlinico Universitario Agostino Gemelli
    Roma, 00168, Italy
  • Hospital Universitario Mutua de Terrassa
    Terrasa, Barcelona 08221, Spain
  • Hospital Universitario Marques de Valdecilla
    Santander, Cantabria 39008, Spain
  • Hospital de Conxo (Santiago de Compostela) GALICIA
    Santiago De Compestela, Pontevedra 15706, Spain
  • Hospital del Mar
    Barcelona, 08003, Spain
  • Vall d'Hebron Institut de Recerca-VHIR
    Barcelona, 08035, Spain
  • Hospital Clinic i Provincial de Barcelona
    Barcelona, 08036, Spain
  • Complejo Hospitalario de Pontevedra
    Pontevedra, 36071, Spain
  • Taipei Medical University Hospital
    Taipei City, 110, Taiwan
  • Chang Gung Memorial Hospital, Linkou
    Taoyuan County, 333, Taiwan
  • The National Hospital for Neurology & Neurosurgery
    London, Greater London WC1N 3BG, United Kingdom
  • Birch Hill Hospital
    Rochdale, Greater Manchester OL12 9QB, United Kingdom
  • The Walton Centre
    Liverpool, Merseyside L9 7LI, United Kingdom
  • Nottingham University Hospitals City Campus
    Nottingham, Nottinghamshire NG5 1PB, United Kingdom
  • Kent and Canterbury Hospital
    Kent, CT1 3NG, United Kingdom
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References and documents

Publications

  • Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7. PubMed 34245684 ↗
  • Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11. PubMed 33151636 ↗
  • Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27. PubMed 31953896 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01930786
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 29, 2013
Start date
Oct 16, 2013
Primary completion
Oct 9, 2017
Completion
Oct 9, 2017
Last update
Feb 11, 2019

Study contacts

Aleks Zuzek
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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