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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00460655 |
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.
Condition | Intervention | Phase |
---|---|---|
Post-Stroke Spasticity |
Drug: GSK1358820 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Lower Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment |
Estimated Enrollment: | 120 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
GSK Investigational Site | |
Tokyo, Japan, 105-8461 | |
GSK Investigational Site | |
Shizuoka, Japan, 410-3293 | |
GSK Investigational Site | |
Kanagawa, Japan, 257-0001 | |
GSK Investigational Site | |
Hiroshima, Japan, 720-0825 | |
GSK Investigational Site | |
Kanagawa, Japan, 253-8558 | |
GSK Investigational Site | |
Hokkaido, Japan, 005-8555 | |
GSK Investigational Site | |
Kanagawa, Japan, 247-8533 | |
GSK Investigational Site | |
Kumamoto, Japan, 860-8518 | |
GSK Investigational Site | |
Ibaraki, Japan, 302-0112 | |
GSK Investigational Site | |
Hiroshima, Japan, 728-0001 | |
GSK Investigational Site | |
Kanagawa, Japan, 227-8518 | |
GSK Investigational Site | |
Shizuoka, Japan, 410-2507 | |
GSK Investigational Site | |
Shizuoka, Japan, 410-1128 | |
GSK Investigational Site | |
Fukuoka, Japan, 811-0213 | |
GSK Investigational Site | |
Hokkaido, Japan, 006-0805 | |
GSK Investigational Site | |
Hokkaido, Japan, 005-0802 | |
GSK Investigational Site | |
Hokkaido, Japan, 053-0803 | |
GSK Investigational Site | |
Yamaguchi, Japan, 740-0021 | |
GSK Investigational Site | |
Tokyo, Japan, 142-8666 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | BTX108512 |
Study First Received: | April 13, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00460655 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Post-Stroke Spasticity Lower Limb botulinum toxin type A |
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 Brain Ischemia Neurologic Manifestations Brain Infarction Botulinum Toxin Type A Infarction |
Neuromuscular Manifestations Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders Signs and Symptoms |
Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Brain Ischemia Neurologic Manifestations Cardiovascular Diseases Brain Infarction |