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Clozapine

Phase 3

Schizophrenia | Small molecule | Psychiatry |Novartis AG|Last Updated: Sep 24, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Clozapine · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00250575A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant SchizophreniaSchizophrenia
COMPLETED43 Analytics
PHASE3COMPLETED
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Schizophrenia
NCT0025057543
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Study Endpoints

Primary Endpoints

Values of hematological tests during the 24 week treatment
Incidence of hematological adverse events during the 24 week treatment
Compliance to Clozapine Patient Monitoring System during the 24 week treatment
Adverse events during the long term treatment (until NDA approval)
Baseline to 52 weeks
Vital signs at every 4 weeks
Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Baseline to 52 weeks
ECG at every 12 weeks
Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Baseline to 52 weeks

Secondary Endpoints

Changes in the symptoms of psychosis every 4 weeks up to week 24
Global change in severity of psychosis at baseline and week 12
Global impression of change in the condition of patients at week 12 and 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
ClozapineDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Diagnosed as schizophrenia * Not responded to at least two atypical antipshychotics launched in Japan * Inpatient Exclusion Criteria: * Low white blood cell count * Significant heart diseases * Diabetes mellitus Other protocol-defined exclusion criteria may apply.

Countries:Japan
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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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