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

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.

Completed

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Key information

Conditions

Mumps Infections Mononegavirales Infections Mouth Diseases Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not applicable

Treatment and study plan

Botulinum Toxin Type A

Drug

Botulinum Toxin Type A

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 11, 2011
Registry last updated: Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed