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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00460564 |
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.
Condition | Intervention | Phase |
---|---|---|
Post-Stroke Spasticity |
Drug: GSK1358820 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Upper Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment |
Estimated Enrollment: | 105 |
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:
Subjects eligible for enrollment in the study must meet all of the following criteria:
1) Patients with upper limb spasticity who are at least 6 months post stroke and present with spasticity of both the wrist and fingers at the start of double-blind phase (Visit 2).
Exclusion Criteria:
Japan | |
GSK Clinical Trials Call Center | |
Miyoshi City, Japan, 728 | |
GSK Clinical Trials Call Center | |
Tomakomai City, Japan, 053 | |
GSK Clinical Trials Call Center | |
Sapporo City, Japan, 005 | |
GSK Clinical Trials Call Center | |
Moriya City, Japan, 360 | |
GSK Clinical Trials Call Center | |
Iwakuni City, Japan, 740 | |
GSK Clinical Trials Call Center | |
Susono City, Japan, 410 | |
GSK Clinical Trials Call Center | |
Hadano City, Japan, 257 | |
GSK Clinical Trials Call Center | |
Sapporo City, Japan, 006 | |
GSK Clinical Trials Call Center | |
Chigasaki City, Japan, 253 | |
GSK Clinical Trials Call Center | |
Kumamoto City, Japan, 860 | |
GSK Clinical Trials Call Center | |
Fukuyama City, Japan, 720 | |
GSK Clinical Trials Call Center | |
Izu City, Japan, 410 | |
GSK Clinical Trials Call Center | |
Yokohama City, Japan, 227 | |
GSK Clinical Trials Call Center | |
Tokyo, Japan, 142 | |
GSK Clinical Trials Call Center | |
Tokyo, Japan, 105 | |
GSK Clinical Trials Call Center | |
Kamakura City, Japan, 247 | |
GSK Clinical Trials Call Center | |
Fukuoka City, Japan, 811 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | BTX108509 |
Study First Received: | April 13, 2007 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00460564 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Post-Stroke Spasticity Upper 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 Nervous System Diseases Cardiovascular Diseases |