Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

This study has been completed.

Sponsor:

Information provided by:

Ipsen

ClinicalTrials.gov Identifier:

NCT00234546

First received: October 6, 2005

Last updated: June 18, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2005

Last Updated Date

June 18, 2012

Start Date ^ICMJE

February 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00234546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Muscle Spasticity
Cerebrovascular Accident

Intervention ^ICMJE

Drug: Botulinum toxin type A (Dysport®)
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
Other: Placebo
1 injection at day 0. The study will last for 6 months in each patient.

Study Arm (s)

Experimental: 1
Dysport

Intervention: Drug: Botulinum toxin type A (Dysport®)
Placebo Comparator: 2
Placebo

Intervention: Other: Placebo

Publications *

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 Controlled Trial. Neurorehabil Neural Repair. 2012 Feb 27. [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

162

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hong Kong, Malaysia, Philippines, Singapore, Thailand

Administrative Information

NCT Number ^ICMJE

NCT00234546

Other Study ID Numbers ^ICMJE

A-38-52120-713

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Axel Magis, MD

Ipsen

Information Provided By

Ipsen

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top