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An Adult Spasticity Registry of OnabotulinumtoxinA Treatment (ASPIRE)

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ClinicalTrials.gov Identifier: NCT01930786
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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 Type : Observational
Actual Enrollment : 746 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : October 7, 2017
Actual Study Completion Date : October 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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




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 ]


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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

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


  Show 55 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Aleks Zuzek Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01930786     History of Changes
Other Study ID Numbers: GMA-BTX-SP-12-001
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
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