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

Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01390922

Enrollment

1038

Registered

2011-07-11

Start date

2011-08-31

Completion date

2014-10-31

Last updated

2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mumps

Brief summary

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.

Interventions

DRUGBotulinum Toxin Type A

Botulinum Toxin Type A

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Not applicable

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026