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
2021
Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis
Johnston K, Popoff E, Deighton A, Dabirvaziri P, Harris L, Thiry A, Croop R, Coric V, L’Italien G, Moren J. Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis. Expert Review Of Pharmacoeconomics & Outcomes Research 2021, 22: 155-166. PMID: 34148501, DOI: 10.1080/14737167.2021.1945444.Peer-Reviewed Original ResearchConceptsPain freedomAcute treatmentAdverse eventsLow dosesSustained pain freedomAbsence of headFixed-effect Bayesian NMAHigh rateStudy 303Acute migraineEfficacy outcomesPain reliefBayesian NMAEfficacy resultsLasmiditanACHIEVE IComparative efficacyHigh dosesHead comparisonRCTsMigraineDosesRelative efficacySomnolenceOutcomesA phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults
Croop R, Ivans A, Anderson M, Stringfellow J, Bertz R, Hanna M, Healy F, Stock D, Coric V, Lipton R. A phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults. Cephalalgia Reports 2021, 4: 25158163211007922. DOI: 10.1177/25158163211007922.Peer-Reviewed Original ResearchPharmacokinetic interactionsSubcutaneous sumatriptanHemodynamic effectsBlood pressureConcomitant administrationDay 1Healthy adultsInjection of sumatriptanPlacebo-controlled studyMean arterial pressureDiastolic blood pressureInjection site reactionsSystolic blood pressureTime-weighted averageAdverse eventsArterial pressureSite reactionsConcomitant useSumatriptanDay 2Day 5Dosed subjectsPlaceboSignificant differencesPhase 1
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 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 ResearchConceptsCGRP 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 ResearchConceptsSmall 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 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 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 ResearchConceptsPercentage 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
2012
Safety and Tolerability of the γ-Secretase Inhibitor Avagacestat in a Phase 2 Study of Mild to Moderate Alzheimer Disease
Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and Tolerability of the γ-Secretase Inhibitor Avagacestat in a Phase 2 Study of Mild to Moderate Alzheimer Disease. JAMA Neurology 2012, 69: 1430-1440. PMID: 22892585, DOI: 10.1001/archneurol.2012.2194.Peer-Reviewed Original ResearchMeSH KeywordsActivities of Daily LivingAgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesAmyloid Precursor Protein SecretasesBody WeightDose-Response Relationship, DrugDouble-Blind MethodEnzyme InhibitorsFemaleHumansImmunoprecipitationInternational CooperationMagnetic Resonance ImagingMaleMass SpectrometryMiddle AgedNeuropsychological TestsOutcome Assessment, Health CareOxadiazolesPsychiatric Status Rating ScalesSulfonamidesTau ProteinsTime FactorsConceptsPhase 2 studyModerate Alzheimer's diseaseAdverse eventsAlzheimer's diseaseDiscontinuation ratesDose groupPharmacodynamic effectsAlzheimer's Disease Assessment Scale-cognitive subscale scoresTreatment-emergent serious adverse eventsDouble-blind treatment phaseΓ-Secretase Inhibitor AvagacestatSerious adverse eventsLow discontinuation rateNonmelanoma skin cancerCognitive subscale scoresDose armBiomarker substudyMedian ageMulticenter trialAcceptable safetyCognitive worseningΕ4 carriersCommon reasonTreatment groupsTreatment phase