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 2/3Rimegepant, 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 outcomesLasmiditanNauseaDizzinessTrialsPlaceboMigraineNNTTreatmentHoursAcute Treatment with Oral Rimegepant 75 mg Reduces Migraine-Related Disability in Adults With and Without a History of Triptan Treatment Failure: Results from a One-Year, Open-Label Safety Study (P2-2.002)
Jensen C, Thiry A, Kim E, Lovergren M, Croop R, Coric V, L‘Italien G, Lipton R. Acute Treatment with Oral Rimegepant 75 mg Reduces Migraine-Related Disability in Adults With and Without a History of Triptan Treatment Failure: Results from a One-Year, Open-Label Safety Study (P2-2.002). Neurology 2022, 98 DOI: 10.1212/wnl.98.18_supplement.873.Peer-Reviewed Original ResearchAn Open-label, Intermediate-sized, Expanded Access Protocol of Rimegepant in the Acute Treatment of Migraine (P2-2.006)
Croop R, Shiovitz T, Khan A, Noonan T, Kaplita S, Seymour E, Jensen C, Coric V. An Open-label, Intermediate-sized, Expanded Access Protocol of Rimegepant in the Acute Treatment of Migraine (P2-2.006). Neurology 2022, 98 DOI: 10.1212/wnl.98.18_supplement.874.Peer-Reviewed Original ResearchAcute treatmentMigraineMonthly 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 historyBaselineRimegepant 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
2021
Comparative 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 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 regimenRimegepant 75 mg is Effective for the Acute Treatment of Migraine Regardless of Attack Frequency: Results From 3 Phase 3 Trials (1212)
Levin M, Buse D, Blumenfeld A, Lipton R, Stock E, Thiry A, Conway C, Jensen C, Morris B, Coric V, Croop R. Rimegepant 75 mg is Effective for the Acute Treatment of Migraine Regardless of Attack Frequency: Results From 3 Phase 3 Trials (1212). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1212.Peer-Reviewed Original ResearchRimegepant 75 mg Results in Reductions in Monthly Migraine Days: Secondary Analysis of a Multicenter, Open Label Long-term Safety Study of Rimegepant for the Acute Treatment of Migraine (1793)
McGinley J, L’Italien G, Thiry A, Croop R, Coric V, Lipton R. Rimegepant 75 mg Results in Reductions in Monthly Migraine Days: Secondary Analysis of a Multicenter, Open Label Long-term Safety Study of Rimegepant for the Acute Treatment of Migraine (1793). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1793.Peer-Reviewed Original ResearchAcute Treatment of Migraine with Oral Rimegepant 75 mg Confers Robust Improvement in Absenteeism, Presenteeism and Productivity: Results from a One Year, Open-Label, Safety Study (BHV3000-201) (1864)
L’Italien G, Croop R, Stock E, Thiry A, Rosenthal H, Lovegren M, Jensen C, Coric V, Lipton R. Acute Treatment of Migraine with Oral Rimegepant 75 mg Confers Robust Improvement in Absenteeism, Presenteeism and Productivity: Results from a One Year, Open-Label, Safety Study (BHV3000-201) (1864). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1864.Peer-Reviewed Original ResearchAcute Treatment with Oral Rimegepant 75mg Reduces Migraine-Related Disability: Results from a One Year, Open-Label Safety Study (BHV3000-201) (1926)
L’Italien G, Croop R, Stock E, Thiry A, Lovegren M, Cowie K, Jensen C, Coric V, Lipton R. Acute Treatment with Oral Rimegepant 75mg Reduces Migraine-Related Disability: Results from a One Year, Open-Label Safety Study (BHV3000-201) (1926). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1926.Peer-Reviewed Original ResearchAcute Treatment of Migraine with Oral Rimegepant 75 mg Improves Health Related Quality of Life: Results from a Long-Term, Open-Label Safety Study (BHV3000-201) (1943)
Harris L, L’Italien G, Croop R, Stock E, Thiry A, Cowrie K, Lovegren M, Jensen C, Coric V, Lipton R. Acute Treatment of Migraine with Oral Rimegepant 75 mg Improves Health Related Quality of Life: Results from a Long-Term, Open-Label Safety Study (BHV3000-201) (1943). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.1943.Peer-Reviewed Original ResearchRimegepant is Effective for the Acute Treatment of Migraine in Subjects Taking Concurrent Preventive Medication: Results From 3 Phase 3 Trials (2091)
Pavlovic J, Dodick D, Newman L, Lipton R, Stock E, Thiry A, Conway C, Jensen C, Morris B, Coric V, Croop R. Rimegepant is Effective for the Acute Treatment of Migraine in Subjects Taking Concurrent Preventive Medication: Results From 3 Phase 3 Trials (2091). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2091.Peer-Reviewed Original ResearchPatient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201) (2112)
Jensen C, Croop R, Lipton R, Stock E, Thiry A, Conway C, Lovegren M, Coric V, L’Italien G. Patient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201) (2112). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2112.Peer-Reviewed Original ResearchRimegepant is Effective for the Acute Treatment of Migraine in Patients Who Have Discontinued or Currently Use Triptans: Results from 3 Phase 3 Clinical Trials (2114)
Croop R, Jensen C, Thiry A, Stock E, Conway C, Morris B, Coric V, Lipton R. Rimegepant is Effective for the Acute Treatment of Migraine in Patients Who Have Discontinued or Currently Use Triptans: Results from 3 Phase 3 Clinical Trials (2114). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.2114.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 ResearchComparative Efficacy and Safety of Rimegepant Versus Ubrogepant and Lasmiditan for Acute Treatment of Migraine: A Network Meta-analysis (NMA) (4369)
Johnston K, Popoff E, Deighton A, Dabirvaziri P, Harris L, Thiry A, Croop R, Coric V, L’Italien G. Comparative Efficacy and Safety of Rimegepant Versus Ubrogepant and Lasmiditan for Acute Treatment of Migraine: A Network Meta-analysis (NMA) (4369). Neurology 2020, 94 DOI: 10.1212/wnl.94.15_supplement.4369.Peer-Reviewed Original Research