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olanzapine-RAIM

Phase 2

Schizophrenia | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: Jun 8, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

olanzapine-RAIM · 1 trial · 1 indication

Phase 2 1
NCT00316238A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With SchizophreniaSchizophrenia
COMPLETED160 Analytics
PHASE2COMPLETED
A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
Schizophrenia
NCT00316238160
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Study Endpoints

Primary Endpoints

To evaluate dose-response relationship and to confirm the efficacy of IM olanzapine by sequentially comparing each of IM olanzapine groups and IM placebo group with respect to the changes from baseline to 2 hours post first IM injection of agitation.

Secondary Endpoints

To determine if the efficacy of IM olanzapine is greater than IM placebo by evaluating sequentially comparing changes at 30 min, 60 min, 90 min post first IM injection of agitation, as measured by the PANSS-EC in schizophrenia patients.
To determine if the efficacy of IM olanzapine groups are greater than the IM placebo by evaluating sequentially changes from baseline to 2 hours post first IM injection in the rate of responder, CGI-I, and ACES.
To examine whether a dose-response relationship exists for IM olanzapine in higher agitation, by using mean changes of PANSS-EC total score from baseline to 2 hours post first IM injection as measured by PANSS-EC (Score total no less than 20).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
olanzapine-RAIMDRUG -
placeboDRUG -
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Eligibility Criteria

Age Range20 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR * Patients must be inpatients during the study * Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less...

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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