Assessments and endpoints
reductions of ≥, deaths, migraine-associated, headaches
ADVERSE EVENTS
The primary efficacy measure was mean change in the number of monthly MHDs from double-blind baseline (the prospective baseline period) to month 6. Secondary endpoints included response rates (based on percent reduction in monthly MHDs from double-blind baseline to month 6), functional outcomes, safety and tolerability.The mean change in monthly MHDs was derived from the ePRO system, in which patients recorded information about headaches (including medication used) and migraine-associated symptoms each day. Response rates were then estimated as the percentage of patients with reductions of ≥ 50%, ≥ 75% and 100% in monthly MHDs from double-blind baseline. A maintained ≥ 50% response was defined as a ≥ 50% reduction in monthly MHDs from baseline to month 3 that was maintained throughout the OLE. Functional outcomes were assessed as described previously [Safety was assessed by monitoring TEAEs, SAEs, deaths, adverse events leading to discontinuation, laboratory tests, electrocardiograms, vital signs, and body weight. Levels of antidrug antibodies (ADA) and neutralizing ADAs were measured to assess immunogenicity. Treatment-emergent ADAs (TE-ADAs) were defined as a negative baseline ADA result followed by a positive post-baseline ADA result with a titer ≥ 1:20 (treatment-induced) or positive baseline and post-baseline ADA results with a ≥ fourfold increase in titer (treatment-boosted ADA).