Inclusion criteria:¹

• Adults aged ≥18 years
• ≥1 year history of migraine with or without aura, or chronic migraine, according to the criteria of the International Classification of Headache Disorders (ICHD), 3rd Edition
• Onset before 50 years of age
• At least 4 but ≤18 migraine attacks/month of moderate-to-severe intensity over a 3 month period or 6 migraine days during 4 week observation period
• Normal findings on medical and laboratory assessments

Exclusion criteria:¹

• More than 18 headache days during the 4 week observation period
• History of non-responsiveness to more than 2 types of preventative migraine treatment
• Had a medical condition that would expose undue risk or interfere with the assessment of efficacy or safety
• Drug or alcohol abuse treatment in the past 12 months
• History of drug or other allergy that made them unsuitable
• Had an ECG or laboratory test findings that raised safety or tolerability concerns

• Change from the 4-week observation period (baseline) in the mean number of migraine days per month in Weeks 9–12

• At least 50% reduction from 4-week observation period (baseline) in mean number of moderate-to-severe MMD in Weeks 9–12
• Change from baseline in MMD across Weeks 1–12
• Mean number of rescue medication days per month in Weeks 9–12
• Change from baseline in MMD during Weeks 1–4

Secondary endpoints related to disability:

• Change from baseline in MSQ role function at Week 12
• Change from baseline in MIDAS total score at Week 12

Secondary endpoints related to safety and tolerability:

• Adverse events
• Serious adverse events
• Adverse events leading to discontinuation
• Clinically significant lab test abnormalities Increases in AST and ALT >3x the ULN, concurrently with bilirubin elevation > 2x the ULN
• Hepatic related adverse events
• Hepatic adverse events leading to discontinuation

CI, confidence interval; MMD, monthly migraine days

MMD, monthly migraine days

• These results were seen in the prophylaxis population studied
• Participants in either group were equally likely to experience an adverse event
• Nearly all adverse events were considered mild or moderate in severity
• No serious adverse events related to treatment were recorded for the rimegepant group, 1 SAE was recorded for placebo group
• Rate of discontinuation due to adverse events was low in both groups (2% (n=7) of rimegepant group and 1% (n=4) of placebo group)
• 4 rimegepant and 2 placebo participants had concentrations of AST and ALT >3x the ULN