Proof of Concept study for GSK249320 versus placebo in Stroke patients

• Research type

  Research Study

• Full title

  Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients

• IRAS ID

  120678

• Contact name

  David Cohen

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2012-004494-23

• ISRCTN Number

  n/a

• Research summary

  This study is to test the safety and efficacy of GSK249320 in patients who have suffered an ischaemic stroke (a stroke caused by a blood clot in the brain). The current main treatment for this kind of stroke must be administered within a few hours after the stroke so can only be used in a small proportion of cases. GSK249320 is a monoclonal antibody which works by blocking a protein in the body called MAG. MAG stops nerve growth after a stroke so by blocking it, nerve growth after a stroke might increase. This may be helpful for treating stroke in the future. This drug has so far been tested in 2 human studies. It has been given to 25 stroke patients in one study and to 31 healthy volunteers in another to test its safety. This study will include up to 162 participants in 4 countries and is sponsored by GlaxoSmithKline.Eligible participants will be between 18-90 years old and must have had a stroke within the last 24-72 hours. They must also have problems with their lower limb function as a result of their stroke.Participants will be given either GSK249320 or placebo (a plain salt water solution), in addition to standard care. This will be given through a drip into a vein in the arm on study days 1 and 6. Participants will then be assessed every 30 days for 3 months and again at 6 months. A follow-up visit may be required later.Assessments will include vital signs (heat rate, breathing rate), ECG, blood samples and other specialised tests. These will include tests for hand movement, coordination and walking. A CT or MRI scan may be required at the first visit and an MRI scan of the brain will be required at the 6 month visit.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  13/LO/0157

• Date of REC Opinion

  18 Mar 2013

• REC opinion

  Further Information Favourable Opinion