2024
CONNEX, a Phase III Randomized Trial Program Assessing Efficacy and Safety of Iclepertin in Schizophrenia: Recruitment and Baseline Characteristics
Blahova Z, Ikezawa S, Falkai P, Krystal J, Rangan T. CONNEX, a Phase III Randomized Trial Program Assessing Efficacy and Safety of Iclepertin in Schizophrenia: Recruitment and Baseline Characteristics. BJPsych Open 2024, 10: s72-s73. DOI: 10.1192/bjo.2024.230.Peer-Reviewed Original ResearchVirtual Reality Functional Capacity Assessment ToolComposite T-scoreSchizophrenia Cognition Rating ScaleSchizophrenia Consensus Cognitive BatteryCognitive impairmentGlycine transporter-1 inhibitorStable antipsychotic treatmentN-methyl-d-aspartate receptor signallingConsensus Cognitive BatteryCognitive remediation therapyIncrease synaptic levelsCognition Rating ScaleT-scoreDuration of illnessCo-agonist glycineAntipsychotic treatmentAntipsychotic medicationSchizophrenia treatmentCognitive batteryRemediation therapyCognitive symptomsTreatment researchSchizophreniaImprove cognitionPlacebo-controlled parallel-group trial
2023
Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program
Wunderlich G, Blahova Z, Hake S, Ikezawa S, Marder S, Falkai P, Krystal J. Efficacy and Safety of Iclepertin (BI 425809) in Patients With Schizophrenia: CONNEX, A Phase III Randomized Controlled Trial Program. CNS Spectrums 2023, 28: 229-229. DOI: 10.1017/s1092852923001530.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsPlacebo-controlled parallel-group trialKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scoreMulti-center studyPhase III programRole of glutamateLong-term safetyScale total scoreDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment toolII trialTolerability dataEfficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme
Falkai P, Reuteman-Fowler C, Blahova Z, Ikezawa S, Marder S, Krystal J. Efficacy and safety of iclepertin (BI 425809) in patients with schizophrenia: CONNEX, a Phase III randomised controlled trial programme. European Psychiatry 2023, 66: s637-s637. PMCID: PMC10661489, DOI: 10.1192/j.eurpsy.2023.1325.Peer-Reviewed Original ResearchCognitive impairmentEfficacy endpointVirtual Reality Functional Capacity Assessment ToolCognitive symptomsJazz PharmaceuticalsPlacebo-controlled parallel-group trialBoehringer IngelheimKey secondary efficacy endpointsN-methyl-D-aspartate receptorsSafety extension studyPrimary efficacy endpointSecondary efficacy endpointsParallel-group trialPhase II trialPoor functional outcomeComposite T-scorePhase III programRole of glutamateLong-term safetyScale total scoreGrant/research supportDemonstration of efficacyGlycine transporter 1Industry-sponsored studiesCapacity assessment tool