Assessments
headache
Following enrolment, a 28-day headache diary was completed [capturing monthly headache days, headache severity (0–10 numerical rating scale), monthly analgesia days]. A telemetric ICP catheter (Raumedic) was implanted prior to the baseline visit through a 4 mm burr hole into the right frontal lobe.At baseline, medical history, examination (including blood pressure and heart rate) and body mass index [BMI; calculated using the formula: BMI = weight (kg) / height (m)Blood samples were collected at baseline pre-dose and post-dose at 2.5 h, 6 h, 11 h, 22 h and 24 h, at 2 weeks (pre- and 2.5 h post-dose) and 12 weeks (pre- and 2.5 h post-dose), to evaluate safety blood tests, pharmacokinetics and antidrug antibodies.ICP was recorded using a transdermal telemetric ICP monitoring system (Raumedic) at baseline, 2.5 h, 24 h and 12 weeks. In the planned exploratory analysis ICP was measured continuously for the first 2.5 h after dosing and then between 24.00 and 07.00 h overnight following the first dose. ICP data were collected at a frequency of 5 Hz and the mean ICP was calculated from each 30 min of continuous ICP monitoring over the first 2.5 h and each hour overnight. ICP was recorded with the MPR-1 monitor (Raumedic) in a standardized supine position as previously described.