An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

Completed

• Conditions: Muscle Spasticity
• Interventions: Drug: onabotulinumtoxinA

• Registration Number: NCT01930786
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Study Start: 2013-10-16
• Primary Completion: 2017-10-09
• Study Completion: 2017-10-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 744

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Reporting Satisfaction with Treatment	5 Weeks
Percentage of Health Care Providers Reporting Satisfaction with Treatment	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Disability Assessment on a 4-Point Scale	12 Weeks
Severity of Pain on an 11-Point Scale	5 Weeks
Physical Functioning on a 5-Point Scale	5 Weeks

Trial Locations

Locations (55)

Loma Linda University School Of Medicine; 🇺🇸 Loma Linda, California, United States

MS Center of California; 🇺🇸 Newport Beach, California, United States

Sutter Health General Hospital; 🇺🇸 Sacramento, California, United States

Design Neuroscience Center; 🇺🇸 Doral, Florida, United States

Brooks Rehabilitation Hospital; 🇺🇸 Jacksonville, Florida, United States

Emerald Coast Center for Neurological Disorders; 🇺🇸 Pensacola, Florida, United States

Gil, Ramon A.; 🇺🇸 Port Charlotte, Florida, United States

Kernan Hospital; 🇺🇸 Baltimore, Maryland, United States

MedTechnical, PLLC; 🇺🇸 Silver Spring, Maryland, United States

Michigan Institute for Neurological Disorders; 🇺🇸 Farmington Hills, Michigan, United States

Scroll for more (45 remaining)