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

Phase 4

Completed

• Conditions: Muscle Spasticity; Cerebrovascular Accident
• Interventions: Biological: Botulinum toxin type A; Drug: Placebo

• Registration Number: NCT00216411
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2006-07-20
• Study Completion: 2006-07-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dysport	Botulinum toxin type A	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

St Josephs Hospital; 🇦🇺 Auburn, New South Wales, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Austin Health; 🇦🇺 Heidelberg, Victoria, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Caulfield General Medical Centre; 🇦🇺 Caulfield, Victoria, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia