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ONO-2333Ms Experimental 2

Phase 2

Major Depressive Disorder | Small molecule | Psychiatry |BrainsWay Ltd.|Last Updated: Nov 28, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment278

FDA Designations

No designations recorded

Clinical trial landscape

ONO-2333Ms Experimental 2 · 1 trial · 1 indication

Phase 2 1
NCT00514865Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive DisorderMajor Depressive Disorder
COMPLETED278 Analytics
PHASE2COMPLETED
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to treatment endpoint in the MADRS total score
8 weeks

Secondary Endpoints

Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental 1EXPERIMENTAL1-2 mg of ONO-2333
Experimental 2EXPERIMENTAL5-10 mg of ONO-2333
PlaceboPLACEBO_COMPARATORplacebo comparator

Interventions

NameTypeDescription
ONO-2333Ms Experimental 2DRUG5-10 mg QD(once a day) for 8 weeks
PlaceboDRUG0 mg QD(once a day) for 8 weeks
ONO-2333Ms Experimental 1DRUG1-2 mg QD(once a day) for 8 weeks
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with recurrent major depressive disorder Exclusion Criteria: * Patients with treatment resistance for depression * History of alcohol abuse/dependence, substance abuse/dependence within 6 months * Has clinically significant unstable medical condition * Has signific...

Countries:United States
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Frequently asked questions about ONO-2333Ms Experimental 2

What is ONO-2333Ms Experimental 2 used for?

ONO-2333Ms Experimental 2 is an investigational small molecule being studied for the treatment of Major Depressive Disorder. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing ONO-2333Ms Experimental 2?

ONO-2333Ms Experimental 2 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The drug is in Phase 2 clinical trials for Major Depressive Disorder.

What phase is ONO-2333Ms Experimental 2 in?

ONO-2333Ms Experimental 2 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. A Phase 2 trial for the drug has been completed.

What clinical trials is ONO-2333Ms Experimental 2 in?

ONO-2333Ms Experimental 2 has one completed clinical trial, identified as NCT00514865. This was a Phase 2, placebo-controlled, double-blind, randomized study in patients with recurrent Major Depressive Disorder, conducted in the United States with 278 participants.

Is ONO-2333Ms Experimental 2 the same as any other drug?

ONO-2333Ms Experimental 2 is also known by the name ONO-2333Ms. The drug is being studied under this name in clinical trials for Major Depressive Disorder.