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olanzapine-RAIM

Phase 2

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

olanzapine-RAIM development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2006

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

olanzapine-RAIM clinical trials

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
SchizophreniaUnlock trial analytics

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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Frequently asked questions about olanzapine-RAIM

What is olanzapine-RAIM?

Olanzapine-RAIM is an investigational rapid acting intramuscular formulation of olanzapine developed by Eli Lilly and Company. It is being studied for the treatment of agitation in patients with schizophrenia. It is a small molecule therapy and remains in clinical development rather than being an approved product.

What is olanzapine-RAIM used for in schizophrenia?

Olanzapine-RAIM is being studied for agitation in patients with schizophrenia. The Phase 2 trial enrolled agitated patients with schizophrenia, and the formulation is designed for intramuscular administration. The program is investigational, and the studied use is specifically agitation in the schizophrenia population rather than schizophrenia maintenance treatment.

Who makes olanzapine-RAIM?

Olanzapine-RAIM is developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this rapid acting intramuscular olanzapine formulation in agitated patients with schizophrenia.

What phase is olanzapine-RAIM in?

Olanzapine-RAIM is in Phase 2 development. The program has one completed Phase 2 trial, and no active trials are currently listed. It is an investigational product and has not been established as an approved treatment.

What clinical trials is olanzapine-RAIM in?

Olanzapine-RAIM has been evaluated in one completed Phase 2 trial, NCT00316238, titled A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia. The trial enrolled 160 patients in Japan, was randomized and double blind, and included participants aged 20 years and older.