Clinical trial NCT00216411: Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Accident
Muscle Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary outcomes:
measure: Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
measure: Change in the Modified Motor Assessment Scale
measure: Change in patient disability and carer burden rating scale total score
measure: Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
measure: Change in the degree of pain
measure: Change in depression rating scale total score
measure: Global assessment of benefit
Other outcomes:
Locations:
city: Auburn
country: Australia
facility: St Josephs Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Caulfield
country: Australia
facility: Caulfield General Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.