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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00234546 |
The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.
Condition | Intervention | Phase |
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Muscle Spasticity Cerebrovascular Accident |
Drug: Botulinum toxin type A (Dysport®) Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week Prospective, Multicentre, Randomised, Double-Blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke. |
Enrollment: | 162 |
Study Start Date: | February 2003 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
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1: Experimental
Dysport
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Drug: Botulinum toxin type A (Dysport®)
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
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2: Placebo Comparator
Placebo
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Other: Placebo
1 injection at day 0. The study will last for 6 months in each patient.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hong Kong | |
Prince of Wales Hospital | |
Shatin, Hong Kong | |
Malaysia | |
University Hospital of Malaya Medical Centre | |
Kuala Lumpur, Malaysia, 59100 | |
Philippines | |
University of Santo Tomas | |
Manila, Philippines, 3001 MAB | |
Singapore | |
TTSH Rehabilitation Centre | |
Singapore, Singapore, 569766 | |
Thailand | |
Siriraj Hospital | |
Bangkok, Thailand, 10700 |
Study Director: | Axel Magis, MD | Ipsen |
Study ID Numbers: | A-38-52120-713 |
Study First Received: | October 6, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00234546 |
Health Authority: | Hong Kong: Hong Kong Hospital Authority; Malaysia: National Pharmaceutical Control Bureau; Philippines: Department of Health; Singapore: Health Sciences Authority; Thailand: The Ethical Committee on Research Involving Human Subjects |
Cerebral Infarction Stroke Vascular Diseases 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 Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Neuromuscular Agents Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |