Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00833989 |
The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to placebo in patients with ischaemic stroke.
Condition | Intervention | Phase |
---|---|---|
Ischaemic Stroke |
Drug: PLACEBO Drug: GSK249320 |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Parallel Assignment, Safety Study |
Official Title: | A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Repeat Doses of GSK249320 in Patients With Ischaemic Stroke |
Estimated Enrollment: | 48 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ACTIVE: Experimental |
Drug: GSK249320
I.V. infusion
|
PLACEBO: Placebo Comparator |
Drug: PLACEBO
Placebo
|
GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to myelin-associated glycoprotein (MAG) and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after ischaemic stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity. The present study is the first in patients with ischaemic stroke. The main aim of this study is to select tolerated doses of GSK249320 that can be used in future trials to evaluate its efficacy in improving clinical function in patients recovering from ischaemic stroke. This clinical trial is designed as a placebo-controlled, single-blind, multicenter study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating repeat IV doses of GSK249320. Three sequential dose escalation cohorts (1, 5 and 15 mg/kg) are planned, with 8 patients on placebo and 8 on active in each cohort. Each patient will receive 2 repeat IV doses 10 ± 1 days apart and assessments will extend to at least 16 weeks.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5. Have an upper and/or lower limb deficit defined as:
Exclusion Criteria:
5. Presence of severe aphasia as defined by a score of 3 on the NIHSS Best Language question (question
14. Contraindication to TMS, such as:
15. Contraindication to MRI, such as:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, California | |
GSK Investigational Site | |
Orange, California, United States, 92868-4280 | |
GSK Investigational Site | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
GSK Investigational Site | |
Fort Collins, Colorado, United States, 80524 | |
United States, Michigan | |
GSK Investigational Site | |
Detroit, Michigan, United States, 48201 | |
United States, Oregon | |
GSK Investigational Site | |
Portland, Oregon, United States, 97239 | |
United States, West Virginia | |
GSK Investigational Site | |
Morgantown, West Virginia, United States, 26506-9180 | |
Canada, Ontario | |
GSK Investigational Site | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Quebec | |
GSK Investigational Site | |
Montreal, Quebec, Canada, H3T 1E2 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111539 |
Study First Received: | January 29, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00833989 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Ischemia Brain Diseases Cerebrovascular Disorders |
Pathologic Processes Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Ischemia Brain Diseases Cerebrovascular Disorders |