• Adults aged ≥18 years
• ≥1 year history of migraine with or without aura, according to the criteria of the 3rd Edition of International Classification of Headache Disorders (ICHD) beta version
• Onset before 50 years of age
• ≥2 but ≤8 migraine attacks/month of moderate-to-severe intensity
• <15 days/month with migraine/non-migraine headache within the past 3 months

• Have a medical condition that may interfere with study assessments
• Been treated for drug or alcohol abuse in the past 12 months
• Had a history of drug or other allergy that made them unsuitable for participation
• Had an ECG or laboratory test findings that raised safety or tolerability concerns

Endpoints²
Co-primary endpoints:

• Freedom from pain at 2 hours post dose
  • Freedom from pain was defined as a reduction in headache severity from moderate/severe at baseline to no pain.
• Freedom from most bothersome symptom (MBS) at 2 hours post dose
  • MBS freedom was defined as the absence of the self-identified MBS. Common MBS included photophobia, nausea and phonophobia

Secondary endpoints (1st category – 2 hours post dose):

• Pain relief, freedom from photophobia, freedom from phonophobia, freedom from nausea and ability to function normally at 2 hours

Secondary endpoints (2nd category – reflect early action):

• Freedom from pain at 90 min, freedom from MBS at 90 min
• At 60 and 90 minutes post dose: pain relief and ability to function normally

Secondary endpoints (3rd category – durability of drug effect)

• At 2–24 hours and 2–48 hours post dose: sustained freedom from pain, sustained freedom from MBS, sustained pain relief and sustained ability to function normally
• Use of rescue medication within 24 hours of dose
• Pain relapse 2–48 hours post dose

Safety and tolerability endpoints:

• Adverse events
• ECG, vital signs, physical measurements
• Routine laboratory tests
• Sheehan Suicidality Tracking Scale (STS)*

End point definitions²

• Pain intensity was measured on a four-point scale (0=none, 1=mild,  2=moderate, 3=severe). Pain relief was also measured using this scale
• The MBS (nausea, phonophobia or photophobia) was measured using a  binary scale (0=absent, 1=present)
• Ability to function normally was measured on a four-point scale (normal  function, mild impairment, severe impairment, or required bedrest)
• The probability of using rescue medication was calculated on the basis of the number of participants in the group who reported using such medications

• To control the type I statistical error rate at 0·05, a hierarchical gate-keeping procedure was applied, with a prespecified sequence of comparisons from the coprimary endpoints through the secondary endpoints in the order listed in the protocol¹ and also listed below ('all primary and secondary endpoints' drop down menu)

This analysis includes only the use of non-steroidal anti-inflammatory drugs, paracetamol, antiemetics or baclofen, within 24 hours post dose; the use of triptans or other acute migraine medication was not allowed. Study was conducted using orally disintegrating tablet formulation of ​rimegepant 75 mg; the formulation of VYDURA used within the UK is oral lyophilisate 75 mg^1,2

Rimegepant works to improve ability to function normally following a migraine attack vs. placebo^1–3