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CompletedNCT00216411Updated Jul 29, 2019

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

A Phase 4 interventional study of Botulinum toxin type A and Placebo in Cerebrovascular Accident and Muscle Spasticity, sponsored by Ipsen. Completed at 6 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-29.

Sponsored by Ipsen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebrovascular Accident
  • Muscle Spasticity
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 96 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Dysport

    Biological: Botulinum toxin type A

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • BiologicalBotulinum toxin type A

    Also known as: AbobotulinumtoxinA (Dysport®)

  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)

  2. Change in the Modified Motor Assessment Scale

  3. Change in patient disability and carer burden rating scale total score

  4. Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)

  5. Change in the degree of pain

  6. Change in depression rating scale total score

  7. Global assessment of benefit

07

Study locations

6 sites
  • St Josephs Hospital
    Auburn, New South Wales 2144, Australia
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
  • Prince of Wales Hospital
    Randwick, New South Wales 2031, Australia
  • Box Hill Hospital
    Box Hill, Victoria 3128, Australia
  • Caulfield General Medical Centre
    Caulfield, Victoria 3162, Australia
  • Austin Health
    Heidelberg, Victoria 3084, Australia
08

References and documents

Publications

  • 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. PubMed 20111849 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00216411
Lead sponsor
Ipsen
First posted
Sep 22, 2005
Start date
Nov 2004
Primary completion
Jul 20, 2006
Completion
Jul 20, 2006
Last update
Jul 29, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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