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

  81824

• Contact name

  David Cohen

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2010-024087-17

• ISRCTN Number

  isrctn

• Research summary

  This is a study 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 3 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 is the second study for this drug in humans. As of June 2011, the study drug had 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 450 participants in 10 countries and is sponsored by GlaxoSmithKline.Eligible participants will be between 18-90 years of age 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.Two groups of participants will be given GSK249320 at different doses and one group will be given a placebo (a plain salt water solution). 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 and leg strength, movement and coordination, walking and balance. A CT or MRI scan of the brain may also be required.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1447

• Date of REC Opinion

  28 Oct 2011

• REC opinion

  Further Information Favourable Opinion