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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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