Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

Cerebrovascular Accident Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216411
• Other study ID #: A-9B-52120-097
• Status: Completed
• Phase: Phase 4
• Start date: November 2004
• Est. completion date: July 20, 2006

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 20, 2006
• Est. primary completion date: July 20, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Muscle Spasticity
• Stroke

Intervention

Biological:
• Botulinum toxin type A

Drug:
• Placebo

Locations

Country	Name	City	State
Australia	St Josephs Hospital	Auburn	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Caulfield General Medical Centre	Caulfield	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary	Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Secondary	Change in the Modified Motor Assessment Scale
Secondary	Change in patient disability and carer burden rating scale total score
Secondary	Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Secondary	Change in the degree of pain
Secondary	Change in depression rating scale total score
Secondary	Global assessment of benefit