An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

NCT ID: NCT01930786

Last Updated: 2019-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

744 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-16

Study Completion Date

2017-10-09

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Spasticity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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onabotulinumtoxinA

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

onabotulinumtoxinA

Intervention Type DRUG

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

Interventions

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onabotulinumtoxinA

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

Intervention Type DRUG

Other Intervention Names

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BOTOX® botulinum toxin Type A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleks Zuzek

Role: STUDY_DIRECTOR

Allergan

Locations

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Loma Linda University School Of Medicine

Loma Linda, California, United States

Site Status

MS Center of California

Newport Beach, California, United States

Site Status

Sutter Health General Hospital

Sacramento, California, United States

Site Status

Design Neuroscience Center

Doral, Florida, United States

Site Status

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Site Status

Emerald Coast Center for Neurological Disorders

Pensacola, Florida, United States

Site Status

Gil, Ramon A.

Port Charlotte, Florida, United States

Site Status

Kernan Hospital

Baltimore, Maryland, United States

Site Status

MedTechnical, PLLC

Silver Spring, Maryland, United States

Site Status

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, United States

Site Status

The Curators of the University of Missouri on behalf of University of Missouri Health Care

Columbia, Missouri, United States

Site Status

Seacoast Physiatry

Exeter, New Hampshire, United States

Site Status

CentraState Medical Center

Freehold, New Jersey, United States

Site Status

Guilford Neurologic Associates

Greensboro, North Carolina, United States

Site Status

Dayton Center for Neurological Disorders

Dayton, Ohio, United States

Site Status

Albert Einstein Healthcare Network, Moss Rehabilitation Hospital

Elkins Park, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Metrolina Neurological Assoc., PA

Rock Hill, South Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status

Center for Neurological Disorders, S.C.

Milwaukee, Wisconsin, United States

Site Status

Hôpital Morvan

Brest, Finistere, France

Site Status

Pôle Saint Helier

Rennes, Ille Et Vilaine, France

Site Status

CHU de Grenoble - Hôpital Sud

Échirolles, Isere, France

Site Status

Hopital Saint Philibert - GHICL Lille

Lomme, Nord, France

Site Status

Centre Hospitalier de Pau

Pau, Pyrenees Atlantiques, France

Site Status

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Site Status

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Leipzig AoeR

Leipzig, Saxony, Germany

Site Status

Universitaetsklinikum Jena

Jena, Thuringia, Germany

Site Status

Parkinson Klinik Wolfach GmbH & Co KG

Baden Wuerttemberg, , Germany

Site Status

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

Azienda Ospedaliero - Universitaria Maggiore delle Carità

Novara, , Italy

Site Status

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital de Conxo (Santiago de Compostela) GALICIA

Santiago de Compestela, Pontevedra, Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Vall d'Hebron Institut de Recerca-VHIR

Barcelona, , Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Site Status

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Site Status

The National Hospital for Neurology & Neurosurgery

London, Greater London, United Kingdom

Site Status

Birch Hill Hospital

Rochdale, Greater Manchester, United Kingdom

Site Status

Kent and Canterbury Hospital

Kent, Kent, United Kingdom

Site Status

The Walton Centre

Liverpool, Merseyside, United Kingdom

Site Status

Nottingham University Hospitals City Campus

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United States France Germany Italy Spain Taiwan United Kingdom

References

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Wissel J, List C, Schwartz M, Nelson M, Musacchio T, Duarte E. Relief of pain associated with spasticity in adult patients after treatment with onabotulinumtoxinA: Post hoc observational results from the ASPIRE study. PM R. 2025 Sep 30. doi: 10.1002/pmrj.70013. Online ahead of print.

Reference Type DERIVED
PMID: 41025675 (View on PubMed)

Bavikatte G, Francisco GE, Jost WH, Baricich A, Duarte E, Tang SFT, Schwartz M, Nelson M, Musacchio T, Esquenazi A. Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study. PM R. 2024 Nov;16(11):1175-1189. doi: 10.1002/pmrj.13195. Epub 2024 May 30.

Reference Type DERIVED
PMID: 38813838 (View on PubMed)

Bavikatte G, Esquenazi A, Dimyan MA, Dashtipour K, Feng W, Mayadev A, Fanning K, Musacchio T, Zuzek A, Francisco GE. Safety and Real-World Dosing of OnabotulinumtoxinA for the Treatment of Adult Spasticity: Post Hoc Analysis of the Adult Spasticity International Registry Study. Am J Phys Med Rehabil. 2024 Jul 1;103(7):580-587. doi: 10.1097/PHM.0000000000002410. Epub 2024 Jan 8.

Reference Type DERIVED
PMID: 38206635 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34245684 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33151636 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31953896 (View on PubMed)

Other Identifiers

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GMA-BTX-SP-12-001

Identifier Type: -

Identifier Source: org_study_id

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