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 phaseRimegepant, 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 outcomesLasmiditanNauseaDizzinessTrialsPlaceboMigraineNNTTreatmentHours
2021
A 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 antagonistPlaceboMigraineMedicationsRimegepantMatching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP Monoclonal Antibodies (mAb) Examining Health-related Quality of Life (HRQoL). (1951)
Popoff E, Johnston K, Harris L, Thiry A, Croop R, Coric V, L’Italien G. Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP Monoclonal Antibodies (mAb) Examining Health-related Quality of Life (HRQoL). (1951). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1951.Peer-Reviewed Original ResearchRimegepant Has No Clinically Relevant Effect on ECG parameters at Therapeutic and Supratherapeutic Doses: A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy Subjects (2117)
Hanna M, Coric V, Stringfellow J, Ivans A, Croop R. Rimegepant Has No Clinically Relevant Effect on ECG parameters at Therapeutic and Supratherapeutic Doses: A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy Subjects (2117). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2117.Peer-Reviewed Original ResearchRimegepant 75 mg Demonstrates Superiority to Placebo on Nausea Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3 Trials in the Acute Treatment of Migraine (2402)
McAllister P, Berman G, Kudrow D, Smith T, Lipton R, Stock E, Stock D, Conway C, Jensen C, Morris B, Coric V, Croop R. Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3 Trials in the Acute Treatment of Migraine (2402). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2402.Peer-Reviewed Original ResearchMatching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP-targeted Monoclonal Antibodies Examining Monthly Migraine Days in the Treatment of Migraine (4563)
Popoff E, Johnston K, Croop R, Thiry A, Harris L, Coric V, L’Italien G. Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP-targeted Monoclonal Antibodies Examining Monthly Migraine Days in the Treatment of Migraine (4563). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.4563.Peer-Reviewed Original Research