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 phase
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 antagonistPlaceboMigraineMedicationsRimegepant
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