Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)

Special Drug Use Investigation for Botox® (Botulinum) Spasticity

The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.

Study Overview

• Status: Completed
• Conditions: Mumps
• Intervention / Treatment: Drug: Botulinum Toxin Type A

• Study Type: Observational
• Enrollment (Actual): 1038

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time

Description

Inclusion Criteria:

• Subjects with upper or lower limb spasticity
• Subjects must use botulinum injection for the first time

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects prescribed botulinum injection	Drug: Botulinum Toxin Type A; Botulinum Toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of adverse events in Japanese subjects with spasticity treated with botulinum injection	1 year
Occurence of adverse events at remote sites	1 year
Occurence of adverse events associated with pulmonary function	1 year
Onset status of adverse events associated with convulsion	1 year
Onset status of adverse events associated with accidents such as fall	1 year

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 114880