Protocol Addendum I5Q-MC-CGAS(1.1) A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine – the REBUILD Study

addendum CGaS(1) is a multicenter, single-dose, open-label trial with 5 study periods in 2 cohorts of pediatric patients with a diagnosis of migraine.in addendum CGaS(1), 120-mg galcanezumab will be administered via subcutaneous injection and patients monitored for a period of 5 months following dosing to evaluate PK, PD, and safety and tolerability [including anti-drug antibodies (aDa)]. Patients who complete the 5-month monitoring period have the option to enter a 9-month open-label treatment phase, receiving 120 mg/monthly of galcanezumab administered via subcutaneous injection. a final 4-month post-treatment phase will follow the open-label treatment phase. at least 24 patients will be enrolled in this addendum, with at least 12 of the patients weighing 30 to 45 kg (30 to [LessThanorequalTo]45 kg) and at least 12 weighing 15 to [Less Than]30 kg (15 to [Less Than]30 kg). adverse events (aes), clinical laboratory parameters, vital signs, and electrocardiogram (eCG) parameters will be summarized using stan[See protocol for complete text]