An Adult Spasticity Registry of OnabotulinumtoxinA Treatment
ASPIRE
ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
1 other identifier
observational
744
7 countries
55
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedStudy Start
First participant enrolled
October 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2017
CompletedFebruary 11, 2019
February 1, 2019
4 years
August 26, 2013
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Patients Reporting Satisfaction with Treatment
5 Weeks
Percentage of Health Care Providers Reporting Satisfaction with Treatment
12 Weeks
Secondary Outcomes (3)
Physical Functioning on a 5-Point Scale
5 Weeks
Severity of Pain on an 11-Point Scale
5 Weeks
Disability Assessment on a 4-Point Scale
12 Weeks
Study Arms (1)
onabotulinumtoxinA
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
Interventions
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
Eligibility Criteria
Patients with Muscle Spasticity
You may qualify if:
- 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
You may not qualify if:
- Concurrent participation in a clinical trial for spasticity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (55)
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, Finistere, 239609, France
Pôle Saint Helier
Rennes, Ille Et Vilaine, 35043, France
CHU de Grenoble - Hôpital Sud
Échirolles, Isere, 38434, France
Hopital Saint Philibert - GHICL Lille
Lomme, Nord, 59160, France
Centre Hospitalier de Pau
Pau, Pyrenees Atlantiques, 64046, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 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
Milan, 20132, Italy
Azienda Ospedaliero - Universitaria Maggiore delle Carità
Novara, 28100, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Hospital Universitario Mutua de Terrassa
Terrassa, 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, 110, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 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
Kent and Canterbury Hospital
Kent, Kent, CT1 3NG, United Kingdom
The Walton Centre
Liverpool, Merseyside, L9 7LI, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (6)
Wissel J, List C, Schwartz M, Nelson M, Musacchio T, Duarte E. Relief of pain associated with spasticity in adult patients after treatment with onabotulinumtoxinA: Post hoc observational results from the ASPIRE study. PM R. 2025 Sep 30. doi: 10.1002/pmrj.70013. Online ahead of print.
PMID: 41025675DERIVEDBavikatte G, Francisco GE, Jost WH, Baricich A, Duarte E, Tang SFT, Schwartz M, Nelson M, Musacchio T, Esquenazi A. Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study. PM R. 2024 Nov;16(11):1175-1189. doi: 10.1002/pmrj.13195. Epub 2024 May 30.
PMID: 38813838DERIVEDBavikatte G, Esquenazi A, Dimyan MA, Dashtipour K, Feng W, Mayadev A, Fanning K, Musacchio T, Zuzek A, Francisco GE. Safety and Real-World Dosing of OnabotulinumtoxinA for the Treatment of Adult Spasticity: Post Hoc Analysis of the Adult Spasticity International Registry Study. Am J Phys Med Rehabil. 2024 Jul 1;103(7):580-587. doi: 10.1097/PHM.0000000000002410. Epub 2024 Jan 8.
PMID: 38206635DERIVEDEsquenazi 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.
PMID: 34245684DERIVEDEsquenazi 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.
PMID: 33151636DERIVEDFrancisco 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.
PMID: 31953896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aleks Zuzek
Allergan
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2013
First Posted
August 29, 2013
Study Start
October 16, 2013
Primary Completion
October 9, 2017
Study Completion
October 9, 2017
Last Updated
February 11, 2019
Record last verified: 2019-02