Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

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

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-07-20

Brief Summary

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The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

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Detailed Description

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Conditions

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Cerebrovascular Accident Muscle Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dysport

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Placebo

Intervention Type DRUG

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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Inclusion Criteria

* The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
* The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
* The patient has the cognitive and communication ability to participate in the study.

Exclusion Criteria

* Patients who have received botulinum toxin treatment within the past 120 days.
* Contraindication to botulinum toxin treatment.
* Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
* Patients who have previously been treated with phenol for their upper limb spasticity.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No