Defining the Clinical Value of Endpoints Used in Migraine Trials

Endpoints in Acute Migraine Clinical Trials

Previously Used Endpoints -- All 4 Required

ICHD-3β Migraine Without Aura

FDA Guidance

Pain + Most Bothersome Symptom = Indication

FDA Guidance Coprimary Endpoints

FDA Guidance Secondary Endpoints

Endpoints in CM Clinical Trials

Translating Endpoints in CM Trials

Migraine Prevalence in the United States

Interpreting Reductions in MDM

Primary and Secondary Endpoints

Outcomes in CM Trials Response Rates

Outcomes in CM Trials Reduction in MSM

Outcomes in CM Trials Migraine-Associated Disability

Outcomes in CM Trials Safety and Tolerability

Concluding Remarks

Abbreviations