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

GlaxoSmithKline1,038 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,038

Conditions

Mumps

Interventions

Botulinum Toxin Type ADRUG

Botulinum Toxin Type A

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with upper or lower limb spasticity * Subjects must use botulinum injection for the first time Exclusion Criteria: * Not applicable

Outcomes

Primary Outcomes

The number of adverse events in Japanese subjects with spasticity treated with botulinum injection

Time frame: 1 year

Occurence of adverse events at remote sites

Time frame: 1 year

Occurence of adverse events associated with pulmonary function

Time frame: 1 year

Onset status of adverse events associated with convulsion

Time frame: 1 year

Onset status of adverse events associated with accidents such as fall

Time frame: 1 year

Data from ClinicalTrials.gov

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