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

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ClinicalTrials.gov Identifier: NCT00216411
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 12, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Muscle Spasticity Drug: Botulinum type A toxin (Dysport) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2004
Estimated Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216411

Australia, New South Wales
St Josephs Hospital
Auburn, New South Wales, Australia, 2144
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Caulfield General Medical Centre
Caulfield, Victoria, Australia, 3162
Austin Health
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Study Director: Hugues Berard, MD Ipsen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216411     History of Changes
Other Study ID Numbers: A-9B-52120-097
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents