Clincosm LogoSign in Get a demo

ASPIRE: An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01930786
Collaborator
(none)
744
Enrollment
55
Locations
47.8
Actual Duration (Months)
13.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
744 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
Actual Study Start Date :
Oct 16, 2013
Actual Primary Completion Date :
Oct 9, 2017
Actual Study Completion Date :
Oct 9, 2017

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Patients Reporting Satisfaction with Treatment [5 Weeks]

    2. Percentage of Health Care Providers Reporting Satisfaction with Treatment [12 Weeks]

    Secondary Outcome Measures

    1. Physical Functioning on a 5-Point Scale [5 Weeks]

    2. Severity of Pain on an 11-Point Scale [5 Weeks]

    3. Disability Assessment on a 4-Point Scale [12 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Aleks Zuzek, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01930786
    Other Study ID Numbers:
    • GMA-BTX-SP-12-001
    First Posted:
    Aug 29, 2013
    Last Update Posted:
    Feb 11, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Muscle Spasticity
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Feb 11, 2019