An Adult Spasticity Registry of OnabotulinumtoxinA Treatment (ASPIRE)

February 7, 2019 updated by: Allergan

ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

744

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Muscle Spasticity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
onabotulinumtoxinA
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
Drug: onabotulinumtoxinA
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Reporting Satisfaction with Treatment
Time Frame: 5 Weeks
5 Weeks
Percentage of Health Care Providers Reporting Satisfaction with Treatment
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical Functioning on a 5-Point Scale
Time Frame: 5 Weeks
5 Weeks
Severity of Pain on an 11-Point Scale
Time Frame: 5 Weeks
5 Weeks
Disability Assessment on a 4-Point Scale
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Aleks Zuzek, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2013

Primary Completion (Actual)

October 9, 2017

Study Completion (Actual)

October 9, 2017

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-BTX-SP-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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