Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT00234546

Collaborator

(none)

162

Enrollment

Locations

Arms

Duration (Months)

32.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity Cerebrovascular Accident	Biological: Botulinum toxin type A Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.

Study Start Date :

Feb 1, 2003

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dysport	Biological: Botulinum toxin type A 1 injection, 500 U at day 0. The study will last for 6 months in each patient. Other Names: AbobotulinumtoxinA (Dysport®)
Placebo Comparator: 2 Placebo	Drug: Placebo 1 injection at day 0. The study will last for 6 months in each patient.

Arm

Intervention/Treatment

Experimental: 1

Dysport

Biological: Botulinum toxin type A

1 injection, 500 U at day 0. The study will last for 6 months in each patient.

Other Names:

AbobotulinumtoxinA (Dysport®)

Placebo Comparator: 2

Placebo

Drug: Placebo

1 injection at day 0. The study will last for 6 months in each patient.

Outcome Measures

Primary Outcome Measures

Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position [week 4]

Secondary Outcome Measures

Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale) [weeks 4, 8, 12 & 24]
Voluntary and passive joint range of motion goniometer assessment [weeks 4, 8, 12 & 24]
Pain Assessment using visual analogue scale for pain [weeks 4, 8, 12 & 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke)
CT/MRI scan required to classify ischaemic / haemorrhagic stroke
Patient recruited 2-12 weeks after stroke
Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint

Exclusion Criteria:

The patient has bleeding disturbances or having used coumarin derivatives
The patient is currently receiving drugs affecting neuromuscular transmission
Co-existing severe systemic illness which may adversely affect the functional outcome
Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Prince of Wales Hospital	Shatin	Hong Kong
2	University Hospital of Malaya Medical Centre	Kuala Lumpur	Malaysia	59100
3	University of Santo Tomas	Manila	Philippines	3001 MAB
4	TTSH Rehabilitation Centre	Singapore	Singapore	569766
5	Siriraj Hospital	Bangkok	Thailand	10700