Trial intelligence / Profile preview

Dysport in early post-stroke upper limb spasticity

NCT00234546Phase 4

Key facts

Status: Completed
Start: Feb 2003
Countries: 5
Sponsor: Ipsen
Modality: Recombinant Proteins and Enzymes

Drugs: abobotulinumtoxinA
Conditions: Spasticity

Overview

Phase 4, randomised, double-blind trial in Spasticity comparing Dysport with Placebo (2 arms). Primary endpoint: Modified Ashworth Scale at 4 weeks. Started Feb 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Dysport
Dysport 500 U injection
Placebo
Placebo injection

Who it enrols

Patients with first-ever stroke (ischaemic or haemorrhagic) recruited 2-12 weeks after stroke with Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint.

Endpoints

Primary

Modified Ashworth Scale4 weeks

Secondary

Modified Ashworth Scale24 weeks
Barthel Index24 weeks
Modified Rankin Scale24 weeks
Motor Assessment Scale24 weeks
Range of Motion24 weeks
Visual Analogue Scale for Pain24 weeks

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