2022
Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double‐blind, randomized, placebo‐controlled, dose‐ranging trial
Croop R, Madonia J, Stock D, Thiry A, Forshaw M, Murphy A, Coric V, Lipton R. Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double‐blind, randomized, placebo‐controlled, dose‐ranging trial. Headache The Journal Of Head And Face Pain 2022, 62: 1153-1163. PMID: 36239038, PMCID: PMC9827820, DOI: 10.1111/head.14389.Peer-Reviewed Original ResearchConceptsAcute treatmentNasal sprayH postdosePain freedomBothersome symptomsAdverse eventsCommon treatment-emergent adverse eventsCalcitonin gene-related peptide receptor antagonistInteractive web response systemTreatment-emergent adverse eventsCoprimary efficacy endpointsMost adverse eventsSevere pain intensityWeb response systemDose-ranging trialFavorable safety profilePeptide receptor antagonistPhase 2/3 trialUS study sitesStudy medicationNasal discomfortCoprimary endpointsEfficacy endpointPain intensityPhase 2/3
2020
Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial
Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. The Lancet 2020, 397: 51-60. PMID: 33338437, DOI: 10.1016/s0140-6736(20)32544-7.Peer-Reviewed Original ResearchConceptsDouble-blind treatment phasePlacebo-controlled trialStudy medicationMigraine daysPreventive treatmentAdverse eventsPhase 2/3Observation periodTreatment phaseWeek 9Calcitonin gene-related peptide receptor antagonistMean numberInteractive web response systemPrimary efficacy endpointWeb response systemPeptide receptor antagonistEfficacy endpointPrimary endpointAcute treatmentEligible participantsReceptor antagonistPlaceboMigraineMedicationsRimegepant
2019
Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial
Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. The Lancet 2019, 394: 737-745. PMID: 31311674, DOI: 10.1016/s0140-6736(19)31606-x.Peer-Reviewed Original ResearchConceptsAcute treatmentAdverse eventsBothersome symptomsH postdoseMigraine attacksSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistInteractive web response systemMulticentre phase 3 trialSevere pain intensitySingle migraine attackCommon adverse eventsPlacebo-controlled trialSerious adverse eventsPhase 3 trialTreatment group assignmentWeb response systemUrinary tract infectionPeptide receptor antagonistHistory of migraineStandard tablet formulationModified intentionStudy medicationTreat populationCoprimary endpoints