Ozanezumab vs Placebo in Amyotrophic Lateral Sclerosis

• Research type

  Research Study

• Full title

  Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

• IRAS ID

  115727

• Contact name

  Karen Morrison

• Eudract number

  2012-003349-13

• ISRCTN Number

  N/A

• Research summary

  This study, sponsored by GlaxoSmithKline, is to test the effect of ozanezumab in patients with amyotrophic lateral sclerosis (ALS). ALS is a type of motor neurone disease where the nerves in the body are gradually destroyed. This causes muscle stiffness and weakness throughout the body which eventually results in difficulty moving, swallowing, speaking and breathing. Life expectancy from onset of symptoms is generally up to 5 years. Ozanezumab is a monoclonal antibody which works by blocking a protein in the body called Nogo-A. Nogo-A may be involved in causing ALS so by blocking it ozanezumab may help treat patients with the condition. Eligible participants will be ALS patients, aged 18 - 80 years, with onset of muscle weakness within the last 30 months. They should not have any other nerve or muscle problems or any severe lung problems. Participants will receive either ozanezumab or placebo (salt water solution) in addition to their usual treatment. It will be given through a drip into a vein (an infusion) every 2 weeks. The first 20 participants will enrol into Part A of the study. Enrolment into Part B will only start once participants in Part A have completed 4 infusions and the results analysed. Part A: Weekly visits for 4 weeks, including 2 overnight stays in hospital to monitor blood pressure and heart rate (vital signs) and heart activity via electrocardiogram (ECG). Visits will then be every 2 weeks and will include at least 3 hours monitoring in hospital. Part B: 2-weekly visits with at least 3 hours monitoring in hospital. Participants will receive study treatment for 48 weeks. Assessments will include vital signs, ECG, various questionnaires, blood tests, lung function and muscle strength tests. After week 48, participants will be asked to return at week 60 for a final follow-up visit.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0389

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion