2022
Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant – post hoc results from an open label safety study (BHV3000–201)
Johnston K, Harris L, Powell L, Popoff E, Coric V, L’Italien G, Schreiber C. Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant – post hoc results from an open label safety study (BHV3000–201). The Journal Of Headache And Pain 2022, 23: 10. PMID: 35038983, PMCID: PMC8903552, DOI: 10.1186/s10194-021-01378-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodHumansMigraine DisordersPiperidinesPyridinesQuality of LifeTreatment OutcomeConceptsMonthly migraine daysMean monthly migraine daysOpen-label safety studyMigraine daysAcute treatmentSafety studiesLabel Safety StudyMedication-related increasesHealth-related qualityMigraine-Specific QualityEQ-5D utilitiesQuality of lifeDaily PRNMethodsEligible subjectsWeek 52PRN basisMigraine attacksIncremental QALYsLife measuresBackgroundThe objectiveOne-yearMigraineFour subjectsYear historyBaseline
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 ResearchMeSH KeywordsAdministration, OralAdultCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodDrug EvaluationFemaleHumansMaleMigraine DisordersPiperidinesPyridinesTreatment OutcomeConceptsDouble-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 antagonistPlaceboMigraineMedicationsRimegepantSafety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine
Berman G, Croop R, Kudrow D, Halverson P, Lovegren M, Thiry A, Conway C, Coric V, Lipton R. Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Headache The Journal Of Head And Face Pain 2020, 60: 1734-1742. PMID: 32799325, PMCID: PMC7496574, DOI: 10.1111/head.13930.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistsDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesPyridinesConceptsCGRP receptor antagonistSmall molecule CGRP receptor antagonistsTreatment adverse eventsCGRP mAbsAdverse eventsAcute treatmentPreventive treatmentReceptor antagonistCalcitonin gene-related peptide (CGRP) ligandOral CGRP receptor antagonistLong-term safety studiesMonoclonal antibodiesCGRP monoclonal antibodiesMonthly migraine attacksOral acute treatmentSevere pain intensitySerious adverse eventsLarger patient populationPrevious case reportsModerate nasopharyngitisStable doseAminotransferase levelsPain intensityAdditional patientsPreventive regimenPotential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy
Mullin K, Kudrow D, Croop R, Lovegren M, Conway C, Coric V, Lipton R. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology 2020, 94: 10.1212/wnl.0000000000008944. PMID: 31932515, PMCID: PMC7526667, DOI: 10.1212/wnl.0000000000008944.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnalgesicsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistsFemaleHumansMigraine DisordersReceptors, Calcitonin Gene-Related PeptideConceptsSmall molecule CGRP receptor antagonistsCGRP receptor antagonistAcute treatmentReceptor antagonistReceptor antibodiesLong-term safety studiesClass IV evidenceRelated adverse eventsFirst clinical reportDrug Administration approvalYears of ageInjectable ketorolacRefractory migraineAcute attacksAdverse eventsSuboptimal responseMigraine medicationsPreventive administrationMigraine therapyPatient 1Patient 2Women 44Case reportConcomitant usePreventive treatment
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 ResearchMeSH KeywordsAdministration, SublingualAdultCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPiperidinesPyridinesTabletsConceptsAcute 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 endpointsRimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine
Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine. New England Journal Of Medicine 2019, 381: 142-149. PMID: 31291516, DOI: 10.1056/nejmoa1811090.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAnalgesicsCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersNauseaPiperidinesPlacebosPyridinesConceptsPercentage of patientsPeptide receptor antagonistPlacebo groupMigraine attacksBothersome symptomsReceptor antagonistCalcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptorGene-related peptide receptorOral Calcitonin GeneSingle migraine attackAcute migraine treatmentCommon adverse eventsPrimary end pointPhase 3 trialUrinary tract infectionOverall mean agePathogenesis of migraineModified intentionAdverse eventsTract infectionsTreat analysisMean ageMigraine treatmentCalcitonin gene