Status:
COMPLETED
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
Lead Sponsor:
Ipsen
Conditions:
Cerebrovascular Accident
Muscle Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 func...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00216411
Start Date
November 1 2004
End Date
July 20 2006
Last Update
July 29 2019
Active Locations (6)
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1
St Josephs Hospital
Auburn, New South Wales, Australia, 2144
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Box Hill Hospital
Box Hill, Victoria, Australia, 3128