2025
Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.
Paz-Ares L, Borghaei H, Liu S, Peters S, Herbst R, Stencel K, Majem M, Czyżewicz G, Bernabe Caro R, Lee K, Johnson M, Karadurmus N, Grohe C, Cuchelkar V, Graupner V, Kaul M, Lin Y, Chakrabarti D, Bhatt K, Reck M. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Journal Of Clinical Oncology 2025, 43: 8006-8006. DOI: 10.1200/jco.2025.43.16_suppl.8006.Peer-Reviewed Original ResearchExtensive-stage small cell lung cancerReceipt of prophylactic cranial irradiationGlobal phase 3 studySmall cell lung cancerProphylactic cranial irradiationPlatinum-based chemotherapySignificant OS benefitPhase 3 studyCell lung cancerClinically meaningful benefitLong-term survivalMaintenance phaseStratified log-rankPD-(L)1RECIST v1.1ECOG PSOS benefitOS improvementCranial irradiationLiver metastasesOpen-labelEligible ptsAggressive diseaseFirst-linePrimary endpointTROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR -mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC).
Lu S, Provencio M, Lisberg A, Mascarenhas E, Tanizaki J, Cheng Y, Kim H, Liu Y, Feng S, Zhang L, Toms L, Yang J, Goldberg S. TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR -mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps8647.Peer-Reviewed Original ResearchProgression-free survivalSafety run-inCentral nervous systemEGFR mutationsPerformance statusSecondary endpointsPhase 3 clinical trial dataEGFR tyrosine kinase inhibitorsRun-inBlinded independent central reviewEGFR mutated NSCLCEGFR mutation typeDuration of responseWHO performance statusIndependent central reviewPhase 3 studyPrimary study endpointTyrosine kinase inhibitorsTopoisomerase I inhibitorAntibody-drug conjugatesMutated NSCLCAdvanced NSCLCIV diseaseNon-squamousOverall survivalPivotal Results of SELECT-MDS-1 Phase 3 Study of Tamibarotene with Azacitidine in Newly Diagnosed Higher-Risk MDS
DeZern A, Thepot S, de Botton S, Patriarca A, Deeren D, Torregrossa-Diaz J, Marconi G, Bernal T, Burgues J, Xicoy B, Jonášová A, Zeidan A, Dimicoli-Salazar S, Simand C, Valcarcel D, Campelo M, Chai-Ho W, Saini L, Garnier A, Geissler K, Ofran Y, Nagy Z, Krishnamurthy P, Lübbert M, Basak G, Carraway H, Sallman D, Borate U, Santini V, Campbell V, Fenaux P, Braun T, Lanza F, Zaucha J, Roth D, Paul S, Roy P, Kelly M, Volkert A, Chisholm J, Malak T, Klimek V, Cluzeau T, Group T. Pivotal Results of SELECT-MDS-1 Phase 3 Study of Tamibarotene with Azacitidine in Newly Diagnosed Higher-Risk MDS. Blood Advances 2025 PMID: 40334070, DOI: 10.1182/bloodadvances.2025016229.Peer-Reviewed Original ResearchHigher-risk MDSIPSS-RBlast count >5%Higher-risk MDS patientsMDS-EB-1Bone marrow blastsPhase 3 studyHigher-risk featuresBlood-based assayGene overexpressionMarrow blastsCR ratePrimary MDSBaseline characteristicsAzacitidineResponse rateNatural historyPatientsTamibaroteneOverexpressionP-valueTreatment effectsExploration of alternative approachesRARAGroupBPI25-014: Pacritinib in Patients With Intermediate-1 Risk Myelofibrosis: Outcomes From Post-Hoc Analysis of Two Phase 3 Studies.
Vachhani P, Podoltsev N, Kishtagari A, Suthar P, Vredenburg M, Roman-Torres K, Gerds A. BPI25-014: Pacritinib in Patients With Intermediate-1 Risk Myelofibrosis: Outcomes From Post-Hoc Analysis of Two Phase 3 Studies. Journal Of The National Comprehensive Cancer Network 2025, 23 PMID: 40154382, DOI: 10.6004/jnccn.2024.7162.Peer-Reviewed Original ResearchA Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus
Peng X, Klingensmith G, Hsia D, Xie Y, Czerniak R, Tamborlane W, Shah A. A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus. Diabetes Therapy 2025, 16: 865-883. PMID: 40032809, PMCID: PMC12006607, DOI: 10.1007/s13300-025-01700-3.Peer-Reviewed Original ResearchType 2 diabetes mellitusAlogliptin treatmentEfficacy endpointPediatric patientsAntihyperglycemic therapyOral dipeptidyl peptidase-4 inhibitorHbA1c levelsRandomized phase 3 studyDipeptidyl peptidase-4 inhibitorsSafety of alogliptinPlacebo-controlled trialPhase 3 studyBaseline to weekPeptidase-4 inhibitorsBody mass indexImprove glycemic controlDouble-blindPlacebo groupSecondary endpointsBackground metforminSchedule APharmacological therapyMass indexGlycosylated hemoglobinInsulin therapyINCIDENCE AND PATHOLOGIC OUTCOMES OF CYSTECTOMY IN PATIENTS WITH BACILLUS CALMETTE-GUÉRIN-UNRESPONSIVE NON–MUSCLE-INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU FOLLOWING TREATMENT WITH NADOFARAGENE FIRADENOVEC-VNCG
Narayan V, Boorjian S, Crispen P, Kamat A, Gomella L, Kates M, Karsh L, Master V, Richards K, Lerner S, Kim E, Inman B, Lane B, Schuckman A, Krupski T, Bardot S, Montgomery J, Busby J, Luchey A, Williams M, Agarwal P, Rehm D, Jakobsen J, Juul K, Dinney C. INCIDENCE AND PATHOLOGIC OUTCOMES OF CYSTECTOMY IN PATIENTS WITH BACILLUS CALMETTE-GUÉRIN-UNRESPONSIVE NON–MUSCLE-INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU FOLLOWING TREATMENT WITH NADOFARAGENE FIRADENOVEC-VNCG. Urologic Oncology Seminars And Original Investigations 2025, 43: 86. DOI: 10.1016/j.urolonc.2024.12.217.Peer-Reviewed Original ResearchBCG-unresponsive NMIBCNon-muscle-invasive bladder cancerCystectomy-free survivalCarcinoma in situNadofaragene firadenovecPhase 3 studyCR statusBladder cancerKaplan-MeierPathological outcomesVector-based gene therapyMedian follow-up timeBladder-sparing optionsHigh-grade recurrenceYears of follow-upRate of upstagingKaplan-Meier (KMAssociated with morbidityData cutoffImmediate cystectomyTransurethral resectionPapillary tumorsOpen-labelDefinitive treatmentEfficacy analysisEfficacy and Safety of Ruxolitinib Cream Monotherapy in Patients Aged 2 Years and Older With Mild-to-Moderate Atopic Dermatitis: Results From 3 Large Randomized Phase 3 Studies
Simpson E, Eichenfield L, Papp K, Kircik L, Blauvelt A, Gold L, Zaenglein A, Lee L, Bunick C, Forman S, Holland K, Kallender H, Sturm D, Ren H, Armstrong A. Efficacy and Safety of Ruxolitinib Cream Monotherapy in Patients Aged 2 Years and Older With Mild-to-Moderate Atopic Dermatitis: Results From 3 Large Randomized Phase 3 Studies. Journal Of Allergy And Clinical Immunology 2025, 155: ab199. DOI: 10.1016/j.jaci.2024.12.618.Peer-Reviewed Original ResearchSafety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study
Antozzi C, Vu T, Ramchandren S, Nowak R, Farmakidis C, Bril V, De Bleecker J, Yang H, Minks E, Park J, Grudniak M, Smilowski M, Sevilla T, Hoffmann S, Sivakumar K, Suzuki Y, Youssef E, Sanga P, Karcher K, Zhu Y, Sheehan J, Sun H, Group T. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. The Lancet Neurology 2025, 24: 105-116. PMID: 39862879, DOI: 10.1016/s1474-4422(24)00498-8.Peer-Reviewed Original ResearchConceptsStandard-of-care therapyLeast-squares mean changeOpen-label extension phaseDouble-blind phasePhase 3 studyPopulation of patientsMyasthenia gravisAdverse eventsAntibody-positivePlacebo groupDouble-blindStudy drugMG-ADLAssociated with dose-dependent reductionsDose of study drugLong-term disease controlMean changeIntention-to-treat populationIncidence of adverse eventsMG-ADL scoresPlacebo-controlled studyGeneralised myasthenia gravisPhase 2 studyBaseline to weekAnti-acetylcholine receptorTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-upevoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease
Cummings J, Atri A, Feldman H, Hansson O, Sano M, Knop F, Johannsen P, León T, Scheltens P. evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer’s disease. Alzheimer's Research & Therapy 2025, 17: 14. PMID: 39780249, PMCID: PMC11708093, DOI: 10.1186/s13195-024-01666-7.Peer-Reviewed Original ResearchConceptsSymptomatic ADAlzheimer's diseaseDouble-blindGlucagon-like peptide-1 receptor agonist semaglutidePlacebo-controlled phase 3 trialOnce-daily oral semaglutideClinical Dementia RatingMild cognitive impairmentAD-related processesAD biomarkersSafety of semaglutideDose-escalation regimenPhase 3 studyBaseline to weekEffect of semaglutidePhase 3 trialCognitive impairmentPathophysiology of Alzheimer's diseasePotential disease-modifying effectsDementia RatingSymptomatic Alzheimer's diseaseTreatment of type 2 diabetesPlacebo-controlledType 2 diabetesDisease-modifying potential
2024
Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients
Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake E, Robertson D, Mendoza J, Lewin J, Everage N, Božin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Advances In Therapy 2024, 42: 395-412. PMID: 39570545, PMCID: PMC11782338, DOI: 10.1007/s12325-024-03047-w.Peer-Reviewed Original ResearchAbsolute lymphocyte countRelapsing-remitting MSEffect of dimethyl fumarateAnnualized relapse rateDisease-modifying therapiesAdverse eventsDimethyl fumarateCD8+ T cell compartmentMultiple sclerosisOlder patientsMedian absolute lymphocyte countOral disease-modifying therapyTreated with dimethyl fumarateSafety outcomesTreating relapsing MST cell compartmentPhase 3 studyResponse to disease-modifying therapiesIncidence of SAEsLymphocyte subset changesReal-world safetyTreatment discontinuationCD4+Immunophenotypic changesRelapse rateEvaluation of Changes in Laboratory Parameters from a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Selective TYK2 Inhibitor, in Patients with Moderate-to-Severe Plaque Psoriasis
Gooderham M, Bunick C, Kircik L, Lynde C, Skov L, Blau J, Zhang W, Uy J, Winkelman W, Thaçi D. Evaluation of Changes in Laboratory Parameters from a Phase 2b Trial of Zasocitinib (TAK-279), an Oral, Selective TYK2 Inhibitor, in Patients with Moderate-to-Severe Plaque Psoriasis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s442. DOI: 10.25251/skin.8.supp.442.Peer-Reviewed Original ResearchPhase 2b trialLaboratory parametersPlaque psoriasisCommon Terminology Criteria for Adverse Events grade 1Adverse Events grade 1Mild to moderate elevationMean triglyceride valuesPhase 3 studyAssessment of laboratory parametersAssociated with rhabdomyolysisTyrosine kinase 2 inhibitorCreatine kinaseJanus kinaseSerum cholesterol levelsDouble-blindPrimary endpointPsoriasis AreaCK elevationStudy treatmentLipid parametersTriglyceride valuesGrade 1PsoriasisCholesterol levelsPatientsHealth-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study
Oliva E, Platzbecker U, Della Porta M, Garcia-Manero G, Santini V, Fenaux P, Shortt J, Komrokji R, Pelligra C, Guo S, Yucel A, Glassberg M, Eliason L, Hnoosh A, Miteva D, Rose S, Kreitz S, Sekeres M, Zeidan A. Health-Related Quality of Life of Luspatercept Versus Epoetin Alfa in Red Blood Cell Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes: Results from the Final Datacut of the Phase 3 COMMANDS Study. Blood 2024, 144: 3216. DOI: 10.1182/blood-2024-198374.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesReduction of red blood cellsFunctional Assessment of Cancer Therapy-AnemiaClinically important differenceEpoetin alfaMyelodysplastic syndromeRevised International Prognostic Scoring SystemInternational Prognostic Scoring SystemHealth-related qualityClinically important difference thresholdImprovement of cytopeniasMean haemoglobin increaseRBC transfusion independencePrognostic Scoring SystemPhase 3 studyStratified Cox proportional hazard regressionsFront-line treatmentOnset of improvementQLQ-C30Cox proportional hazards regressionEORTC QLQ-C30Treatment of anemiaProportional hazards regressionSuperior treatment effectsPost-baseline assessmentRenew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)
Komrokji R, Diez-Campelo M, Chee L, Cluzeau T, DeZern A, Fenaux P, Garcia-Manero G, Giagounidis A, Platzbecker U, Della Porta M, Santini V, Sekeres M, Zeidan A, Buckstein R, Ross M, Jiang Y, Bobba S, Hankin M, Materna C, Graham C, Thamake S, Rovaldi C, Grayson D, Salstrom J. Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS). Blood 2024, 144: 3228.1-3228.1. DOI: 10.1182/blood-2024-200797.Peer-Reviewed Original ResearchDurability of responseMyelodysplastic neoplasmsFollow-up periodTransfusion burdenProportion of participantsAdverse eventsTransfusion independenceIneffective hematopoiesisDouble-blindPlacebo-controlled phase 3 studyAchievement of transfusion independenceMultiple stages of hematopoiesisSafety follow-up periodDouble-blind treatment periodLong-term follow-up periodSeverity of adverse eventsLong-term follow-upErythroid maturation agentLow transfusion burdenSustained hematologic improvementTreatment of transfusion-dependent anemiaPlacebo-controlled studyTransfusion-dependent anemiaPhase 3 studyProgression to AMLBEING ATTACK-FREE WITH GARADACIMAB IMPROVES QUALITY OF LIFE IN PATIENTS WITH HEREDITARY ANGIOEDEMA
Hsu F, Lumry W, Aygoren-Pursun E, Braverman J, Lawo J, Pollen M, Nenci C, Craig T. BEING ATTACK-FREE WITH GARADACIMAB IMPROVES QUALITY OF LIFE IN PATIENTS WITH HEREDITARY ANGIOEDEMA. Annals Of Allergy Asthma & Immunology 2024, 133: s33-s34. DOI: 10.1016/j.anai.2024.08.129.Peer-Reviewed Original ResearchOpen-label extensionAttack-free patientsHereditary angioedemaHRQoL improvementAttack-freeImpaired health-related quality of lifeHealth-related quality of lifeAE-QoLClinically meaningful HRQoL improvementAssociated with HRQoL improvementsExposure cohortPhase 3 studySustained HRQoL improvementQuality of lifePost hoc analysisHRQoL outcomesScore reductionHRQoLPatientsHoc analysisCohortTreatment goalsImpairment scoresAngioedemaDisease controlCHARACTERIZATION OF INJECTION SITE-RELATED ADVERSE EVENTS WITH GARADACIMAB IN PATIENTS WITH HEREDITARY ANGIOEDEMA
Jacobs J, Manning M, Reshef A, Yamagami K, Shetty H, Lawo J, Pollen M, Hsu F. CHARACTERIZATION OF INJECTION SITE-RELATED ADVERSE EVENTS WITH GARADACIMAB IN PATIENTS WITH HEREDITARY ANGIOEDEMA. Annals Of Allergy Asthma & Immunology 2024, 133: s30-s31. DOI: 10.1016/j.anai.2024.08.121.Peer-Reviewed Original ResearchInjection-site reactionsLong-term prophylaxisHereditary angioedemaReduce treatment burdenIncidence of injection-site reactionsInjection-site adverse eventsPhase 3 clinical programTreatment burdenInjection site-relatedPlacebo-receiving patientsPhase 3 studyStudy treatment groupsFavorable safety profileLife-threatening attacksTotal disease controlOnce-monthlySafety profileAdverse eventsPhase 3Clinical studiesPatient proportionErythemaPatientsMonoclonal antibodiesPruritusCost-effectiveness of iptacopan for paroxysmal nocturnal hemoglobinuria
Ito S, Chetlapalli K, Wang D, Potnis K, Richmond R, Krumholz H, Lee A, Cuker A, Goshua G. Cost-effectiveness of iptacopan for paroxysmal nocturnal hemoglobinuria. Blood 2024, 145: 127-140. PMID: 39374533, PMCID: PMC11738035, DOI: 10.1182/blood.2024025176.Peer-Reviewed Original ResearchStandard-of-careParoxysmal nocturnal hemoglobinuriaIncremental net monetary benefitNocturnal hemoglobinuriaComplement-mediated hemolytic anemiaTreating paroxysmal nocturnal hemoglobinuriaComplement C5 inhibitor eculizumabPhase 3 studyQuality-adjusted life expectancyRare blood disorderComprehensive cost-effectiveness analysisProbabilistic sensitivity analysesCost-saving thresholdsC5 inhibitor eculizumabNet monetary benefitPersistent anemiaIptacopanExtravascular hemolysisIntravenous infusionMonotherapyHemolytic anemiaAnemia resolutionC5 inhibitionFDA approvalPrimary outcomeP1.13A.01 DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer
Dowlati A, Hummel H, Paz-Ares L, Blackhall F, Chiang A, Goldman J, Izumi H, Mok T, Sands J, Martinez P, Anderson E, Hamidi A, Yu B, Yu Y, Provencio M. P1.13A.01 DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer. Journal Of Thoracic Oncology 2024, 19: s206. DOI: 10.1016/j.jtho.2024.09.371.Peer-Reviewed Original ResearchClindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.
Lain E, Bhatia N, Kircik L, Gold L, Harper J, Bunick C, Guenin E, Baldwin H, Feldman S, Rosso J. Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis. Journal Of Drugs In Dermatology 2024, 23: 873-881. PMID: 39361705, DOI: 10.36849/jdd.2024.8484.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsModerate-to-severe acneWeeks of once-daily treatmentInflammatory/noninflammatory lesion countsMild to moderate severityTriple-combination treatmentOnce-daily treatmentBaseline to weekPhase 3 studyTreatment success rateQuality-of-life improvementAcne-specific quality of lifePost hoc analysisCutaneous safety/tolerabilityFixed-doseVehicle gelDouble-blindNoninflammatory lesionsFemale acneNo significant differenceImpact of sexEfficacy measuresLesion countsAdverse eventsTreatment successValidating new symptom emergence as a patient-centric outcome measure for PD clinical trials
Zou H, Stebbins G, Simuni T, Luo S, Cedarbaum J. Validating new symptom emergence as a patient-centric outcome measure for PD clinical trials. Parkinsonism & Related Disorders 2024, 128: 107118. PMID: 39353265, DOI: 10.1016/j.parkreldis.2024.107118.Peer-Reviewed Original ResearchPD clinical trialsClinical trialsEmergent symptomsPhase 3 clinical trialsPhase 3 studySlowing of disease progressionOutcome measuresParkinson's diseaseDe novo Parkinson's diseaseMDS-UPDRSItem-level dataFrequency of ESSymptomatic medicationsFrequent administrationMonths of observationEfficacy assessmentDisease progressionSymptom emergenceRating ScaleItem responsesIb and IIUrate elevationTrials
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