Clinical trial NCT01930786: An Adult Spasticity Registry of OnabotulinumtoxinA Treatment
Official title: ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Muscle Spasticity

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.


Eligibility criteria: 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:

* Concurrent participation in a clinical trial for spasticity

Primary outcomes:
measure: Percentage of Patients Reporting Satisfaction with Treatment
timeFrame: 5 Weeks
measure: Percentage of Health Care Providers Reporting Satisfaction with Treatment
timeFrame: 12 Weeks
Secondary outcomes:
measure: Physical Functioning on a 5-Point Scale
timeFrame: 5 Weeks
measure: Severity of Pain on an 11-Point Scale
timeFrame: 5 Weeks
measure: Disability Assessment on a 4-Point Scale
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School Of Medicine
state: California
city: Newport Beach
country: United States
facility: MS Center of California
state: California
city: Sacramento
country: United States
facility: Sutter Health General Hospital
state: California
city: Doral
country: United States
facility: Design Neuroscience Center
state: Florida
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Hospital
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Center for Neurological Disorders
state: Florida
city: Port Charlotte
country: United States
facility: Gil, Ramon A.
state: Florida
city: Baltimore
country: United States
facility: Kernan Hospital
state: Maryland
city: Silver Spring
country: United States
facility: MedTechnical, PLLC
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders
state: Michigan
city: Columbia
country: United States
facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care
state: Missouri
city: Exeter
country: United States
facility: Seacoast Physiatry
state: New Hampshire
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Dayton
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Elkins Park
country: United States
facility: Albert Einstein Healthcare Network, Moss Rehabilitation Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rock Hill
country: United States
facility: Metrolina Neurological Assoc., PA
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Milwaukee
country: United States
facility: Center for Neurological Disorders, S.C.
state: Wisconsin
city: Brest cedex 2
country: France
facility: Hôpital Morvan
state: Finistere
city: Rennes cedex
country: France
facility: Pôle Saint Helier
state: Ille Et Vilaine
city: Echirolles cedex
country: France
facility: CHU de Grenoble - Hôpital Sud
state: Isere
city: Lomme Cedex
country: France
facility: Hopital Saint Philibert - GHICL Lille
state: Nord
city: Pau cedex
country: France
facility: Centre Hospitalier de Pau
state: Pyrenees Atlantiques
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden Wuerttemberg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein Westfalen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
state: Sachsen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thueringen
city: Baden Wuerttemberg
country: Germany
facility: Parkinson Klinik Wolfach GmbH & Co KG
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Terrasa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago De Compestela
country: Spain
facility: Hospital de Conxo (Santiago de Compostela) GALICIA
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Vall d'Hebron Institut de Recerca-VHIR
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: London
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery
state: Greater London
city: Rochdale
country: United Kingdom
facility: Birch Hill Hospital
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: The Walton Centre
state: Merseyside
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
state: Nottinghamshire
city: Kent
country: United Kingdom
facility: Kent and Canterbury Hospital
Study officials:
affiliation: Allergan
name: Aleks Zuzek
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.