NCT01390922

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

July 7, 2011

Last Update Submit

March 26, 2015

Conditions

Mumps

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Subjects prescribed botulinum injection

Subjects prescribed botulinum injection

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ADRUG

Botulinum Toxin Type A

Subjects prescribed botulinum injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mumps

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Rubulavirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03