Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00234546

Purpose

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	Intervention	Phase
Muscle Spasticity Cerebrovascular Accident	Drug: Botulinum toxin type A (Dysport®) Other: Placebo	Phase IV

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Ipsen:

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 [ Time Frame: 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) [ 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 ]

Enrollment:	162
Study Start Date:	February 2003
Study Completion Date:	October 2007

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234546

Locations

Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Malaysia
University Hospital of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Philippines
University of Santo Tomas
Manila, Philippines, 3001 MAB
Singapore
TTSH Rehabilitation Centre
Singapore, Singapore, 569766
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Axel Magis, MD

Ipsen

More Information

Study ID Numbers:	A-38-52120-713
Study First Received:	October 6, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00234546
Health Authority:	Hong Kong: Hong Kong Hospital Authority; Malaysia: National Pharmaceutical Control Bureau; Philippines: Department of Health; Singapore: Health Sciences Authority; Thailand: The Ethical Committee on Research Involving Human Subjects

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Muscle Spasticity

Botulinum Toxins
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Botulinum Toxin Type A
Infarction

Additional relevant MeSH terms:

Neuromuscular Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Neuromuscular Agents
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009