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. 2019 Apr 6;59(5):819–824. doi: 10.1111/head.13511

Table 1.

Study Design for Included Trials

Study Clinicaltrials.gov Identifier Active Intervention Primary Efficacy Endpoint(s) Secondary Efficacy Endpoint(s) Number Randomized, Number in mITT Number Randomized/Number Treatment Groups
ACHIEVE I8
NCT02828020
Ubrogepant 50 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐24 hours sustained pain freedom

  • 2‐hour pain relief

  • 2‐24 hours sustained pain relief

  • Absence/presence of individual non‐headache migraine symptoms at 2 hours9

1672, 1327 557
ACHIEVE II7
NCT02867709
Ubrogepant 50 mg§
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐24 hours sustained pain freedom

  • 2‐hour pain relief

  • 2‐24 hours sustained pain relief

  • Absence/presence of individual non‐headache migraine symptoms at 2 hours9

1686, 1355 562
RESTOR6
NCT02569853
DFN‐11 (Sumatriptan injection 3 mg)
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • Pain freedom at earlier postdose time points

268, NR 134
SPARTAN10
NCT02605174
Lasmitidan 200 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐hour pain relief

  • 2‐hour headache recurrence

  • 2‐hour use of rescue medication

  • 24‐hour use of rescue medication

  • Absence of individual non‐headache migraine symptoms at 2 hours9

3005, 2156 751
SAMURAI11
NCT02439320
Lasmitidan 200 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐hour pain relief, 2‐hour headache recurrence

  • 2‐hour use of rescue medication

  • 24‐hour use of rescue medication

  • Absence of individual non‐headache migraine symptoms at 2 hours9

2232,12 NR 743
Study 30113
NCT03235479
Rimegepant 75 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐24 hours sustained pain freedom

  • 2‐hour pain relief

  • 24‐hour use of rescue medication

  • 2‐24 hours sustained pain freedom

  • Absence of individual non‐headache migraine symptoms at 2 hours

  • 2‐24 and 2‐48 hours sustained pain relief

  • 2 hours functional disability score, 2‐48 hours pain relapse9

1162, 1084 581
Study 30214
NCT03237845
Rimegepant 75 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 2‐24 hours sustained pain freedom

  • 2‐hour pain relief

  • 24‐hour use of rescue medication

  • 2‐24 hours sustained pain freedom

  • Absence of individual non‐headache migraine symptoms at 2 hours

  • 2‐24 and 2‐48 hours sustained pain relief

  • 2‐hour functional disability score

  • 2‐48 hours pain relapse9

1186, 1072 593
ZOTRIP15 ADAM zolmitriptan 3.8 mg
  • 2‐hour headache freedom

  • 2‐hour MBS freedom

  • 0.25‐4 hours pain relief

  • 0.5‐40 hours pain freedom

  • Absence of individual non‐headache migraine symptoms at 2 hours

  • Use of rescue medication during the 2 hours postdose period

365, 360 91

Additional dose was 100 mg.

Photophobia, phonophobia, nausea.

§

Additional dose was 25 mg.

Additional doses were 100 mg, 50 mg.

**

Additional dose was 100 mg.

††

Enrolled.

‡‡

Additional doses were 1 mg, 1.9 mg.

MBS = most bothersome symptom; mITT = modified intent to treat population; NR = not reported.