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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00216411 |
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 | Intervention | Phase |
---|---|---|
Cerebrovascular Accident Muscle Spasticity |
Drug: Botulinum type A toxin (Dysport) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 102 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | October 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
St Josephs Hospital | |
Auburn, New South Wales, Australia, 2144 | |
Prince of Wales Hospital | |
Randwick, New South Wales, Australia, 2031 | |
Royal Prince Alfred Hospital | |
Camperdown, New South Wales, Australia, 2050 | |
Australia, Victoria | |
Box Hill Hospital | |
Box Hill, Victoria, Australia, 3128 | |
Caulfield General Medical Centre | |
Caulfield, Victoria, Australia, 3162 | |
Austin Health | |
Heidelberg, Victoria, Australia, 3084 |
Study Director: | Hugues Berard, MD | Ipsen |
Study ID Numbers: | A-9B-52120-097 |
Study First Received: | September 13, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00216411 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Cerebral Infarction Stroke Vascular Diseases Quality of Life Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders Signs and Symptoms Muscle Spasticity |
Botulinum Toxins Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations Brain Ischemia Brain Infarction Botulinum Toxin Type A Infarction |
Neuromuscular Manifestations Physiological Effects of Drugs Nervous System Diseases Neuromuscular Agents |
Cardiovascular Diseases Peripheral Nervous System Agents Pharmacologic Actions |