2022
Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305)
Powell L, L’Italien G, Popoff E, Johnston K, O’Sullivan F, Harris L, Croop R, Coric V, Lipton R. Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Advances In Therapy 2022, 40: 585-600. PMID: 36417057, PMCID: PMC9898331, DOI: 10.1007/s12325-022-02369-x.Peer-Reviewed Original ResearchConceptsOpen-label extensionEQ-5D utilitiesWeek 12EQ-5DLong-term health-related qualityDouble-blind treatment phaseDouble-blind treatmentPrevention of migraineHealth-related qualityLife Questionnaire version 2.1Migraine-Specific QualityInfluence of treatmentHRQoL improvementResultsBaseline dataIntroductionThe objectiveAdult patientsPoint patientsActive treatmentTrial armsHRQOL measuresPreventive effectPreventive treatmentPlaceboLabel extensionTreatment phaseA stated preference survey to explore patient preferences for novel preventive migraine treatments
Hubig L, Smith T, Chua G, Lloyd A, Powell L, Johnston K, Harris L, L'Italien G, Coric V, Lo S. A stated preference survey to explore patient preferences for novel preventive migraine treatments. Headache The Journal Of Head And Face Pain 2022, 62: 1187-1197. PMID: 36047857, PMCID: PMC9826196, DOI: 10.1111/head.14386.Peer-Reviewed Original ResearchConceptsPatient preferencesTreatment effectivenessCGRP inhibitorsMigraine frequencyMigraine severityPreventive treatmentOral tabletsSemi-structured patient interviewsOnline discrete choice experiment surveyCalcitonin gene-related peptide (CGRP) inhibitorsPreventive migraine treatmentMonoclonal antibody treatmentSeverity of migraineMode of administrationDiscrete choice experiment surveyHypothetical treatment choicesQuarterly injectionsMonthly injectionsOral therapyAntibody treatmentMigraine treatmentPrescribing choicesPatient interviewsSubgroup analysisTreatment preferencesReal-World experience of interictal burden and treatment in migraine: a qualitative interview study
Lo S, Gallop K, Smith T, Powell L, Johnston K, Hubig L, Williams E, Coric V, Harris L, L’Italien G, Lloyd A. Real-World experience of interictal burden and treatment in migraine: a qualitative interview study. The Journal Of Headache And Pain 2022, 23: 65. PMID: 35676636, PMCID: PMC9174626, DOI: 10.1186/s10194-022-01429-5.Peer-Reviewed Original ResearchConceptsMigraine attacksInterictal burdenMigraine symptomsPreventive treatmentHealth-related qualityMonoclonal antibody treatmentSubgroup of patientsEffective treatment optionSelf-reported diagnosisBreakthrough attacksCGRP mAbsHRQL impactAntibody treatmentMigraine painMigraine treatmentTreatment optionsTreatment administrationQualitative interview studyMigraine impactLifestyle changesPatient's perspectiveTreatment experienceSide effectsPatient experienceConclusionThis studyP‐Glycoprotein and Breast Cancer Resistance Protein Transporter Inhibition by Cyclosporine and Quinidine on the Pharmacokinetics of Oral Rimegepant in Healthy Subjects
Bhardwaj R, Collins J, Stringfellow J, Madonia J, Anderson M, Finley J, Stock D, Coric V, Croop R, Bertz R. P‐Glycoprotein and Breast Cancer Resistance Protein Transporter Inhibition by Cyclosporine and Quinidine on the Pharmacokinetics of Oral Rimegepant in Healthy Subjects. Clinical Pharmacology In Drug Development 2022, 11: 889-897. PMID: 35304977, PMCID: PMC9311059, DOI: 10.1002/cpdd.1088.Peer-Reviewed Original ResearchConceptsBreast cancer resistance protein transporterPlasma concentration-time curveSingle oral doseGeometric mean ratiosConcentration-time curveP-glycoproteinOral doseHealthy subjectsSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistStrong P-glycoprotein inhibitorBreast cancer resistance protein (BCRP) inhibitionPeptide receptor antagonistTime 0Mean ratioP-glycoprotein inhibitorsP-glycoprotein transporterConcomitant administrationCrossover studyReceptor antagonistPreventive treatmentCyclosporineCoadministrationTransporter inhibitionPharmacokineticsRimegepant 75 mg for acute treatment of migraine is associated with significant reduction in monthly migraine days: Results from a long-term, open-label study
L’Italien G, Popoff E, Johnston K, McGrath D, Conway C, Powell L, Harris L, Kowalczyk N, Croop R, Coric V. Rimegepant 75 mg for acute treatment of migraine is associated with significant reduction in monthly migraine days: Results from a long-term, open-label study. Cephalalgia Reports 2022, 5: 25158163221075596. DOI: 10.1177/25158163221075596.Peer-Reviewed Original ResearchMonthly migraine daysBaseline monthly migraine daysAcute treatmentMigraine daysMedian timeMigraine frequencyOral calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistOpen-label safety studyBaseline migraine frequencyCGRP receptor blockadeOpen-label studyPeptide receptor antagonistMMD reductionReceptor blockadeMigraine attacksReceptor antagonistPreventive treatmentOutcome measuresResponse rateMigraineSafety studiesTreatmentStudy objectiveSignificant reduction
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