Effects on Quality of Life Following Dysport Treatment in Post-Stroke Spasticity of the Arm
Information source: Ipsen
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebrovascular Accident; Muscle Spasticity
Intervention: Botulinum type A toxin (Dysport) (Drug)
Phase: Phase 4
Status: No longer recruiting
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Hugues Berard, MD, Study Director, Affiliation: Ipsen
Summary
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.
Clinical Details
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
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
St Josephs Hospital, Auburn, New South Wales 2144, Australia
Prince of Wales Hospital, Randwick, New South Wales 2031, Australia
Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia
Austin Health, Heidelberg, Victoria 3084, Australia
Caulfield General Medical Centre, Caulfield, Victoria 3162, Australia
Box Hill Hospital, Box Hill, Victoria 3128, Australia
Additional Information
Starting date:
November 2004
Ending date: July 2006
Last updated: March 20, 2007
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