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Defining the Clinical Value of Endpoints Used in Migraine Trials

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Presentation on theme: "Defining the Clinical Value of Endpoints Used in Migraine Trials"— Presentation transcript:

1 Defining the Clinical Value of Endpoints Used in Migraine Trials

2 Endpoints in Acute Migraine Clinical Trials

3 Previously Used Endpoints -- All 4 Required

4 ICHD-3β Migraine Without Aura

5 FDA Guidance

6 Pain + Most Bothersome Symptom = Indication

7 FDA Guidance Coprimary Endpoints

8 FDA Guidance Secondary Endpoints

9 Endpoints in CM Clinical Trials

10 Translating Endpoints in CM Trials

11 Migraine Prevalence in the United States

12 Interpreting Reductions in MDM

13 Primary and Secondary Endpoints

14 Outcomes in CM Trials Response Rates

15 Outcomes in CM Trials Reduction in MSM

16 Outcomes in CM Trials Migraine-Associated Disability

17 Outcomes in CM Trials Safety and Tolerability

18 Concluding Remarks

19 Abbreviations


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