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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01390922
First received: July 7, 2011
Last updated: March 26, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention
Mumps
Drug: Botulinum Toxin Type A

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Botox® (Botulinum) Spasticity

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1038
Study Start Date: August 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed botulinum injection
Subjects prescribed botulinum injection
Drug: Botulinum Toxin Type A
Botulinum Toxin Type A

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390922

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390922     History of Changes
Other Study ID Numbers: 114880 
Study First Received: July 7, 2011
Last Updated: March 26, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 21, 2016