Thanks @arkangel256.Apart from the primary and second outcomes...

Thanks @arkangel256.

Apart from the primary and second outcomes of the trial, which we’ve previously discussed, a few other features of the trial fill me with confidence:

· High proportion of patients enrolled after screening (16/18 or 89%, with 15/18 or 83% attending a baseline visit).

· All randomised pts completed the 12-week duration of the trial.

· Basic medical and demographics between the intervention and placebo arms were pretty well-matched (e.g., age, BMI, ICP at baseline; but we note that headache days were higher in Exenatide group)

· Only 12 adverse events were reported during the trial, with 8 occurring in the Exenatide arm. 7/8 AEs were nausea, which typically dissipated over the first week. Importantly, no pts withdrew due to AEs. See AEs associated with Acetazolamide (i.e., 48% of pts withdrew over a 3-month period).

· Only 2 of 7 pts on Exenatide developed Exenatide antibodies by week 12.

· No hypoglycaemia was encountered during the trial.

· Significant difference in ICP between arms at the last reading on the first night (p=0.04) – highlighting Exenatide’s rapid onset.

· No significant reduction in body weight at 12 weeks in the treatment arm, so the reduction in ICP was most likely due tothe reduction in CSF secretion and not through weight loss.

· As the authors mention, the above point is important and highlights the huge potential Exenatide can have in other indications – e.g., hydrocephalus, TBI, stroke and meningitis, and space flight (neuro-ocular syndrome).

All of the above bodes well for the Phase 3 trial. While the study design of the P3 is different, hopefully we can recruit pts quickly, with a low number of AEs and withdrawals.