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An Adult Spasticity Registry of OnabotulinumtoxinA Treatment (ASPIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930786
First Posted: August 29, 2013
Last Update Posted: October 13, 2017
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.
Information provided by (Responsible Party):
Allergan
  Purpose
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 Intervention
Muscle Spasticity Drug: onabotulinumtoxinA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

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

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

Enrollment: 746
Actual Study Start Date: September 1, 2013
Study Completion Date: October 7, 2017
Primary Completion Date: October 7, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01930786     History of Changes
Other Study ID Numbers: GMA-BTX-SP-12-001
First Submitted: August 26, 2013
First Posted: August 29, 2013
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