Overview

This trial is active, not recruiting.

Condition muscle spasticity
Treatment onabotulinumtoxina
Sponsor Allergan
Start date September 2013
End date September 2017
Trial size 746 participants
Trial identifier NCT01930786, GMA-BTX-SP-12-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
onabotulinumtoxina BOTOX®
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Allergan.