Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Cerebrovascular Accident Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234546
• Other study ID #: A-38-52120-713
• Status: Completed
• Phase: Phase 4
• Start date: February 2003
• Est. completion date: October 2007

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Muscle Spasticity
• Stroke

Intervention

Biological:
• Botulinum toxin type A
1 injection, 500 U at day 0. The study will last for 6 months in each patient.

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin
Malaysia	University Hospital of Malaya Medical Centre	Kuala Lumpur
Philippines	University of Santo Tomas	Manila
Singapore	TTSH Rehabilitation Centre	Singapore
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Hong Kong,  Malaysia,  Philippines,  Singapore,  Thailand, 

References & Publications (1)

Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VC, Delgado-De Los Santos MM, Chua KS, Abdullah SJ, Zakine B, Maisonobe P, Magis A, Wong KS. Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized con — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Voluntary and passive joint range of motion goniometer assessment		weeks 4, 8, 12 & 24
Secondary	Pain Assessment using visual analogue scale for pain		weeks 4, 8, 12 & 24