{
  "abstract": "Objective This randomized, double-blind, phase 2/3 trial evaluated rimegepant for acute treatment of migraine in participants living in Japan.Methods Participants treated a single migraine attack of moderate or severe pain intensity with rimegepant 25 mg, rimegepant 75 mg, or placebo. Primary endpoint was participants (%) with pain freedom at 2 h postdose; secondary endpoints included pain relief, most bothersome symptom freedom, return to normal function (all at 2 h postdose), and sustained pain relief and sustained pain freedom (each through 2–24 and 2–48 h postdose). Formal hypothesis testing was conducted for rimegepant 75 mg vs placebo. Adverse events (AEs) were assessed.Results 706 treated participants were evaluated. Response rates for the primary endpoint were 21.0% (rimegepant 25 mg), 32.4% (rimegepant 75 mg), and 13.0% (placebo); difference for rimegepant 75 mg vs placebo = 19.4% [95% CI 12.0, 26.8], p<0.0001). Secondary endpoint findings were consistent with the primary endpoint. Any on-treatment AEs were experienced by 7.1% (rimegepant 25 mg), 9.2% (rimegepant 75 mg) and 6.6% (placebo) of participants.Conclusions Rimegepant 75 mg demonstrated efficacy superior to placebo for acute treatment of migraine, with a favourable safety profile, in participants in Japan. A dose-response relationship was observed for rimegepant.grant.oneil@pfizer.com",
  "authors": [
    {
      "affiliations": [
        "Sendai Headache and Neurology Clinic, Japan"
      ],
      "name": "Matsumori Yasuhiko"
    },
    {
      "affiliations": [
        "Ikeda Neurosurgical Clinic, Japan"
      ],
      "name": "Ikeda Koichi"
    },
    {
      "affiliations": [
        "Iwate Medical University, Japan"
      ],
      "name": "Kudo Masako"
    },
    {
      "affiliations": [
        "Pfizer RandD, Japan"
      ],
      "name": "Ishikawa Tomofumi"
    },
    {
      "affiliations": [
        "Pfizer RandD, Japan"
      ],
      "name": "Yoshimatsu Hiroki"
    },
    {
      "affiliations": [
        "Pfizer, Groton"
      ],
      "name": "Thiry Alexandra"
    },
    {
      "affiliations": [
        "Biohaven Pharmaceuticals, New Haven"
      ],
      "name": "Croop Robert"
    },
    {
      "affiliations": [
        "Pfizer, Groton"
      ],
      "name": "Fullerton Terence"
    },
    {
      "affiliations": [
        "Saitama International Headache Center, Japan"
      ],
      "name": "Sakai Fumihiko"
    },
    {
      "affiliations": [
        "Tominaga Hospital, Japan"
      ],
      "name": "Takeshima Takao"
    }
  ],
  "title": "165 Efficacy and safety of rimegepant for the acute treatment of migraine in Japan",
  "uid": "f72871af-093a-527e-814b-413aca3d41bd"
}