Effects on Quality of Life Following Dysport Treatment in Post-Stroke Spasticity of the Arm - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00216411

Purpose

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

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

MedlinePlus related topics: Botox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Phase IV, Multicentre, Placebo-Controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients

Further study details as provided by Ipsen:

Primary Outcome Measures:

Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).

Secondary Outcome Measures:

Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Change in the Modified Motor Assessment Scale
Change in patient disability and carer burden rating scale total score
Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Change in the degree of pain
Change in depression rating scale total score
Global assessment of benefit

Estimated Enrollment:	102
Study Start Date:	November 2004
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
The patient has the cognitive and communication ability to participate in the study.

Exclusion Criteria:

Patients who have received botulinum toxin treatment within the past 120 days.
Contraindication to botulinum toxin treatment.
Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
Patients who have previously been treated with phenol for their upper limb spasticity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216411

Locations

Australia, New South Wales
St Josephs Hospital
Auburn, New South Wales, Australia, 2144
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Caulfield General Medical Centre
Caulfield, Victoria, Australia, 3162
Austin Health
Heidelberg, Victoria, Australia, 3084

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Hugues Berard, MD

Ipsen

More Information

Study ID Numbers:	A-9B-52120-097
Study First Received:	September 13, 2005
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00216411
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Quality of Life
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
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents

Cardiovascular Diseases
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009