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Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

NCT ID: NCT00076687

Last Updated: 2011-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Detailed Description

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Conditions

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Stroke Muscle Spasticity Motor Neuron Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18

2

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18

3

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Saline injection at Day 1, Week 12, Week 18

Interventions

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botulinum toxin Type A

botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18

Intervention Type BIOLOGICAL

botulinum toxin Type A

botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18

Intervention Type BIOLOGICAL

saline

Saline injection at Day 1, Week 12, Week 18

Intervention Type DRUG

Other Intervention Names

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BOTOX® BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Abnormal pulmonary function test results;
* focal, upper limb spasticity, upper motor neuron syndrome

Exclusion Criteria

* Previous exposure to botulinum toxin of any serotype
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Miami, Florida, United States

Site Status

Prague, , Czechia

Site Status

Szeged, , Hungary

Site Status

Warsaw, , Poland

Site Status

Countries

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United States Czechia Hungary Poland

Other Identifiers

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191622-057

Identifier Type: -

Identifier Source: org_study_id