Proof of Concept (POC) in Patients With Ischaemic Stroke

Exclusion Criteria

• •Ability to walk \>0.8m/s as measured by the Gait Velocity assessment.
• •History of a previous symptomatic stroke within 3 months prior to study entry.
• •Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke Rankin score of \>2.
• •Subjects who are not alert or are unresponsive as defined by a score of 2 or 3 on the NIHSS Level of Consciousness question (Question 1a).
• •Presence of significant aphasia likely to confound or interfere with completion of the study assessments.
• •Presence of a significant pre-existing gait deficit prior to study entry that is likely to confound clinical evaluations
• •Presence of pre-existing neurologic or psychiatric disease which is active and not adequately controlled such that it interfered with major activities of daily living immediately prior to the current stroke and is likely to interfere with study participation/visits or confound clinical evaluations.
• •The subject poses a significant suicide risk, in the opinion of the investigator.
• •Current or chronic history of liver disease, known hepatic or biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones), or known history of hepatitis B or hepatitis C infection. A positive hepatitis B or hepatitis C result on the GSK labs drawn at baseline/Study Day 1 do not exclude a subject from continuing in the study unless there are associated clinical signs/symptoms of liver disease; however, the subject should be treated as clinically indicated and the GSK Medical Monitor should be contacted for further discussion.
• •Presence of either a central or peripheral demyelinating disease, such as multiple sclerosis or IgM monoclonal gammopathy of unknown significance (MGUS).
• •Expected death due to the incident stroke, or evidence of a chronic co-morbid condition or unstable acute systemic illness which, in the opinion of the investigator, could shorten the subject's survival such that it would limit his/her ability to complete the study.
• •Participation in any investigational rehabilitation paradigm targeting stroke recovery during the duration of this study.
• •Have a contraindication to MRI as per local hospital practice/guidelines.
• •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• •Prior treatment with GSK249320.
• •History of sensitivity to Investigational Product excipients (acetate buffer, polysorbate 80 and sodium chloride) that, in the opinion of the investigator or GSK Medical Monitor, contraindicates the subject's participation.
• •Pregnant females as determined by positive urine hCG test prior to enrollment.
• •Lactating females.
• •Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol.