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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01390922
First received: July 7, 2011
Last updated: June 6, 2013
Last verified: August 2011
History of Changes

July 7, 2011
June 6, 2013
August 2011
October 2013   (final data collection date for primary outcome measure)
  • The number of adverse events in Japanese subjects with spasticity treated with botulinum injection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurence of adverse events at remote sites [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Occurence of adverse events associated with pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Onset status of adverse events associated with convulsion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Onset status of adverse events associated with accidents such as fall [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01390922 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time
Mumps
Drug: Botulinum Toxin Type A
Subjects prescribed botulinum injection
Intervention: Drug: Botulinum Toxin Type A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
January 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01390922
114880
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP