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Completed

NCT Number: NCT00216411

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

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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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Josephs Hospital, Auburn, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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