An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

Muscle Spasticity Clinical Trial

— ASPIRE  

Official title:

ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930786
• Other study ID #: GMA-BTX-SP-12-001
• Status: Completed
• Start date: October 16, 2013
• Est. completion date: October 9, 2017

Study information

• Verified date: February 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: October 9, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Reporting Satisfaction with Treatment		5 Weeks
Primary	Percentage of Health Care Providers Reporting Satisfaction with Treatment		12 Weeks
Secondary	Physical Functioning on a 5-Point Scale		5 Weeks
Secondary	Severity of Pain on an 11-Point Scale		5 Weeks
Secondary	Disability Assessment on a 4-Point Scale		12 Weeks