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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00460564 |
Purpose
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) |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | BTX108509 |
| Study First Received: | April 13, 2007 |
| Last Updated: | March 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00460564 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Post-Stroke Spasticity Upper Limb botulinum toxin type A |
|
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 |