2022
Ataxia Rating Scales Reflect Patient Experience: an Examination of the Relationship Between Clinician Assessments of Cerebellar Ataxia and Patient-Reported Outcomes
Potashman M, Mize M, Beiner M, Pierce S, Coric V, Schmahmann J. Ataxia Rating Scales Reflect Patient Experience: an Examination of the Relationship Between Clinician Assessments of Cerebellar Ataxia and Patient-Reported Outcomes. The Cerebellum 2022, 22: 1257-1273. PMID: 36495470, PMCID: PMC10657309, DOI: 10.1007/s12311-022-01494-1.Peer-Reviewed Original ResearchConceptsClinical outcome assessmentPatient reported symptomsImpact of illnessPatient experienceAtaxia Rating ScaleReported symptomsRating ScaleAtaxia patientsPatients/familiesMuscle discomfortMotor syndromeCerebellar motor syndromeClinician assessmentOutcome measuresClinical measuresInvoluntary movementsPatientsOutcome assessmentCerebellar ataxiaSymptomsVision impairmentMuscle controlAtaxiaHand coordinationReal-life impactHealth 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 phaseZavegepant 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 2/3Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm
Johnston K, Powell L, Popoff E, Harris L, Croop R, Coric V, L’Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. The Clinical Journal Of Pain 2022, 38: 680-685. PMID: 36125279, PMCID: PMC9555761, DOI: 10.1097/ajp.0000000000001072.Peer-Reviewed Original ResearchConceptsBenefit-risk profilePain freedomPain reliefAcute treatmentRisk differenceMost bothersome symptomsSustained pain reliefFixed-effect Bayesian NMALasmiditan 200Lasmiditan 50Lowest NNTPooled placeboBothersome symptomsBayesian NMAClinical trialsSafety outcomesLasmiditanNauseaDizzinessTrialsPlaceboMigraineNNTTreatmentHoursA 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 preferencesMeasuring interictal burden among people affected by migraine: a descriptive survey study
Hubig L, Smith T, Williams E, Powell L, Johnston K, Harris L, L’Italien G, Coric V, Lloyd A, Lo S. Measuring interictal burden among people affected by migraine: a descriptive survey study. The Journal Of Headache And Pain 2022, 23: 97. PMID: 35941572, PMCID: PMC9358846, DOI: 10.1186/s10194-022-01467-z.Peer-Reviewed Original ResearchConceptsMonthly migraine daysMonthly headache daysInterictal burdenMAb treatmentHIT-6Calcitonin gene-related peptide monoclonal antibodiesMean HIT-6 scoreOverall disease burdenHealth-related qualityIndependent positive associationHeadache Impact TestHIT-6 scoresImpact of migrainePeptide monoclonal antibodyMigraine-free daysPositive associationCross-sectional online surveyMigraine daysPatient characteristicsPatient demographicsMigraine frequencyHeadache daysMigraine attacksMigraine episodesBurden ScaleReal-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 studyReal‐world assessment of the relationship between migraine‐related disability and healthcare costs in the United States
Harris L, L’Italien G, Kumar A, Seelam P, LaVallee C, Coric V, Lipton R. Real‐world assessment of the relationship between migraine‐related disability and healthcare costs in the United States. Headache The Journal Of Head And Face Pain 2022, 62: 473-481. PMID: 35343590, PMCID: PMC9313575, DOI: 10.1111/head.14289.Peer-Reviewed Original ResearchConceptsMigraine-related disabilityDirect medical costsMedical costsIVB patientsEpisodic migrainePharmacy costsGrade IMigraine Disability Assessment Scale (MIDAS) questionnaireMigraine Disability Assessment ScoreHealthcare resource utilizationMigraine Disability AssessmentPrimary care settingElectronic health record dataSubstantial economic burdenHigher medical costsHealth record dataPublic health concernCost-effective treatmentRevision 9Cohort studyHealthcare visitsMIDAS scoreMigraine disabilitySpecialty careReal-world assessmentP‐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 inhibitionPharmacokineticsHuman Milk and Plasma Pharmacokinetics of Single-Dose Rimegepant 75 mg in Healthy Lactating Women
Baker T, Croop R, Kamen L, Price P, Stock D, Ivans A, Bhardwaj R, Anderson M, Madonia J, Stringfellow J, Bertz R, Coric V, Hale T. Human Milk and Plasma Pharmacokinetics of Single-Dose Rimegepant 75 mg in Healthy Lactating Women. Breastfeeding Medicine 2022, 17: 277-282. PMID: 35049333, PMCID: PMC8972016, DOI: 10.1089/bfm.2021.0250.Peer-Reviewed Original ResearchConceptsRelative infant doseHealthy lactating womenHuman milkMaternal doseInfant doseLactating womenSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistMean relative infant doseStudy drug administrationSingle-center studyMaternal body weightPeptide receptor antagonistBody mass indexTreatment of migraineHuman milk samplesPlasma drug concentration ratioDrug concentration ratioWeight-adjusted basisConcentration-time profilesHours postdoseMaternal dosesUncomplicated deliveryMass indexMean ageMonthly 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 ResearchConceptsMonthly 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
2021
Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant
Johnston K, L’Italien G, Popoff E, Powell L, Croop R, Thiry A, Harris L, Coric V, Lipton R. Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant. Advances In Therapy 2021, 38: 5209-5220. PMID: 34455556, PMCID: PMC8478726, DOI: 10.1007/s12325-021-01897-2.Peer-Reviewed Original ResearchConceptsMonthly migraine daysPRN groupMigraine-Specific QualityEQ-5DPRN armLong-term safety studiesHealth state utilitiesMigraine daysEpisodic migraineMethodsStudy participantsTreatment regimensWeek 12Study visitNeurological conditionsSafety studiesBaselineDay scheduleState utilitiesPatientsUtility valuesPRNOutcomesQODGroupDaysComparative 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 efficacySomnolenceOutcomesMatching‐adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health‐related quality of life in the treatment of migraine
Popoff E, Johnston K, Croop R, Thiry A, Harris L, Powell L, Coric V, L’Italien G, Moren J. Matching‐adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health‐related quality of life in the treatment of migraine. Headache The Journal Of Head And Face Pain 2021, 61: 906-915. PMID: 34021585, PMCID: PMC8361942, DOI: 10.1111/head.14128.Peer-Reviewed Original ResearchConceptsMonthly migraine daysMatching-adjusted indirect comparisonHealth-related qualityEVOLVE trialSTRIVE trialBaseline characteristicsMigraine daysIndirect comparisonSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistLong-term preventive effectsAnti-CGRP monoclonal antibodiesMean differencePlacebo-controlled trialPeptide receptor antagonistSingle-arm trialTreatment of migraineVersion 2 scoreMigraine-Specific QualityAssessment test scoreAcute treatmentRandomized trialsWeek 12HRQoL dataReceptor antagonistNovel acute therapies in the treatment of migraine: impact of re-dosing on cost–utility outcomes
Johnston K, L'italien G, Harris L, Deighton A, Popoff E, Croop R, Coric V. Novel acute therapies in the treatment of migraine: impact of re-dosing on cost–utility outcomes. Journal Of Medical Economics 2021, 24: 512-513. PMID: 33843409, DOI: 10.1080/13696998.2021.1915600.Peer-Reviewed Original Research
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 regimenAssessing Effects of BHV-0223 40 mg Zydis Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym
Longo D, Shoda L, Howell B, Coric V, Berman R, Qureshi I. Assessing Effects of BHV-0223 40 mg Zydis Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym. Toxicological Sciences 2020, 175: 292-300. PMID: 32040174, PMCID: PMC7253195, DOI: 10.1093/toxsci/kfaa019.Peer-Reviewed Original ResearchConceptsOral tabletsALT elevationLiver toxicityClinical dataFirst-pass liver metabolismLiver function test parametersFirst-pass hepatic metabolismLiver toxicity riskAlanine transaminase levelsRelative risk reductionLower overall doseAmyotrophic lateral sclerosisALT levelsTransaminase levelsLiver exposureSublingual formulationHepatic metabolismLateral sclerosisRiluzoleLiver metabolismULNInterindividual variabilityOverall doseHepatotoxicity potentialOxidative stressPotential 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 endpoints