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

Mumps Clinical Trial

Official title:

Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390922
• Other study ID #: 114880
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: March 26, 2015
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with upper or lower limb spasticity

• Subjects must use botulinum injection for the first time

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Mumps

Intervention

Drug:
• Botulinum Toxin Type A
Botulinum Toxin Type A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse events in Japanese subjects with spasticity treated with botulinum injection		1 year	Yes
Primary	Occurence of adverse events at remote sites		1 year	Yes
Primary	Occurence of adverse events associated with pulmonary function		1 year	Yes
Primary	Onset status of adverse events associated with convulsion		1 year	Yes
Primary	Onset status of adverse events associated with accidents such as fall		1 year	Yes