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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00216411
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 12, 2007
Information provided by:

September 13, 2005
September 22, 2005
October 12, 2007
November 2004
Not Provided
Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Same as current
Complete list of historical versions of study NCT00216411 on Archive Site
  • 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
Same as current
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Effects on Quality of Life Following Dysport Treatment in Post-Stroke Spasticity of the Arm
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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Cerebrovascular Accident
  • Muscle Spasticity
Drug: Botulinum type A toxin (Dysport)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2006
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Hugues Berard, MD Ipsen
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP