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An Adult Spasticity Registry of OnabotulinumtoxinA Treatment (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01930786
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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
Muscle Spasticity Drug: onabotulinumtoxinA

Study Design
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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 : October 16, 2013
Actual Primary Completion Date : October 9, 2017
Actual Study Completion Date : October 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients Reporting Satisfaction with Treatment [ Time Frame: 5 Weeks ]
  2. Percentage of Health Care Providers Reporting Satisfaction with Treatment [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Physical Functioning on a 5-Point Scale [ Time Frame: 5 Weeks ]
  2. Severity of Pain on an 11-Point Scale [ Time Frame: 5 Weeks ]
  3. Disability Assessment on a 4-Point Scale [ Time Frame: 12 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Muscle Spasticity
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930786


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Aleks Zuzek Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01930786    
Other Study ID Numbers: GMA-BTX-SP-12-001
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents