Key Secondary Efficacy Endpoints Clause Samples

Key Secondary Efficacy Endpoints. Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. • Mean change in the number of days using rescue medication (triptan, ergot derivative, or other migraine-specific acute medication) from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. • Proportion of patients with a PGIC rating of 1, “very much improved”, or 2, “much improved”, at Week 12. • Mean change in the number of moderate or severe headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. A moderate or severe headache day is defined as any calendar day wherein a patient records a headache or migraine of moderate or severe peak intensity in the e-diary. • Mean change in the number of migraine headache days from the last 28 days of Baseline to average number per 28 days over the entire 12-week duration of Treatment Period. • Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) at Week 12

Key Secondary Efficacy Endpoints. The first two secondary efficacy endpoints listed below are considered key secondary endpoints and will be tested in that order: • CGI-I score (analyzed as a continuous variable) after 12 weeks of treatment. • Change from baseline in the SDS total score after 12 weeks of treatment. A fixed sequence procedure will be applied to the key secondary efficacy endpoints to adjust for multiplicity and to control for overall type I error.