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

NCT ID: NCT01390922

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1038 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mumps

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed botulinum injection

Subjects prescribed botulinum injection

Botulinum Toxin Type A

Intervention Type DRUG

Botulinum Toxin Type A

Interventions

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Botulinum Toxin Type A

Botulinum Toxin Type A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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114880

Identifier Type: -

Identifier Source: org_study_id

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