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 2/3P‐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 age
2021
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
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 antagonist
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 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
2015
Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial
Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurology 2015, 72: 1324-1333. PMID: 26414022, DOI: 10.1001/jamaneurol.2015.0607.Peer-Reviewed Original ResearchConceptsNonmelanoma skin cancerObservational cohortProdromal Alzheimer's diseaseProdromal ADClinical trialsPositron emission tomographyAlzheimer's diseaseDiscontinuation ratesCSF biomarkersBiomarker criteriaTreatment phasePlacebo-controlled phase 2 clinical trialSkin cancerGastrointestinal tract adverse eventsKey clinical outcome measuresSerious adverse event ratesΓ-Secretase Inhibitor AvagacestatEmission tomographyPhase 2 clinical trialPotential disease-modifying agentsBrain atrophy ratesLow discontinuation rateAdverse event ratesDisease-modifying agentsGreater brain atrophy
2013
Sheehan Suicidality Tracking Scale (S-STS): Reliability, convergent and discriminative validity in young Italian adults
Preti A, Sheehan D, Coric V, Distinto M, Pitanti M, Vacca I, Siddi A, Masala C, Petretto D. Sheehan Suicidality Tracking Scale (S-STS): Reliability, convergent and discriminative validity in young Italian adults. Comprehensive Psychiatry 2013, 54: 842-849. PMID: 23618606, DOI: 10.1016/j.comppsych.2013.03.012.Peer-Reviewed Original ResearchConceptsSuicidal behaviorSheehan Suicidality Tracking ScaleS-STSTreatment-emergent suicidal ideationPsychological distressClinician-Administered Rating ScaleSocial supportTest-retest stabilitySuicide ideationDivergent validityInternal consistencyCross-sectional designHigh riskSuicidal ideationScreening toolRating Scale
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
2010
Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder
Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang S, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder. Depression And Anxiety 2010, 27: 417-425. PMID: 20455246, DOI: 10.1002/da.20695.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAnti-Anxiety AgentsAnxiety DisordersCitalopramDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedPharmacogeneticsPhenotypePolymorphism, Single NucleotidePsychometricsPyrazolesReceptors, Corticotropin-Releasing HormoneSeverity of Illness IndexTriazinesYoung AdultConceptsGeneralized anxiety disorderSingle nucleotide polymorphismsHamilton Anxiety Scale (HAMA) total scoreAnxiety disordersFactor receptor 1 antagonistActive comparator armCorticotropin-releasing factor receptorsActive comparator trialsPlacebo-controlled trialCorticotropin-releasing factor receptor 1 antagonistTreatment of GADPrimary outcome measurePlexin-A2Receptor 1 antagonistScale total scoreCRF-1 receptor antagonistClass of agentsComparator trialsComparator armPrimary outcomeActive comparatorEntire cohortRandomized subjectsReceptor antagonistMean change
2005
Initial evidence of the beneficial effects of glutamate-modulating agents in the treatment of self-injurious behavior associated with borderline personality disorder.
Pittenger C, Krystal JH, Coric V. Initial evidence of the beneficial effects of glutamate-modulating agents in the treatment of self-injurious behavior associated with borderline personality disorder. The Journal Of Clinical Psychiatry 2005, 66: 1492-3. PMID: 16420092, DOI: 10.4088/jcp.v66n1121d.Peer-Reviewed Original ResearchRiluzole Augmentation in Treatment-Resistant Obsessive–Compulsive Disorder: An Open-Label Trial
Coric V, Taskiran S, Pittenger C, Wasylink S, Mathalon DH, Valentine G, Saksa J, Wu YT, Gueorguieva R, Sanacora G, Malison RT, Krystal JH. Riluzole Augmentation in Treatment-Resistant Obsessive–Compulsive Disorder: An Open-Label Trial. Biological Psychiatry 2005, 58: 424-428. PMID: 15993857, DOI: 10.1016/j.biopsych.2005.04.043.Peer-Reviewed Original ResearchConceptsTreatment-resistant obsessive-compulsive disorderObsessive-compulsive disorderYale-Brown Obsessive Compulsive ScaleY-BOCS scoresTreatment-resistant OCD patientsAddition of riluzolePractical clinical benefitOpen-label trialGlutamate-modulating agentsSerious adverse effectsHamilton Depression InventoryAnxiety Inventory scoresObsessive Compulsive ScaleMost patientsStandard therapyGlutamatergic dysfunctionAugmentation therapyClinical benefitPrimary diagnosisStandard treatmentCorticostriatal pathwayTreatment respondersRiluzolePatientsDepression Inventory