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ONO-4641

Phase 2

Multiple Sclerosis | Small molecule | Neurology |BrainsWay Ltd.|Last Updated: Dec 25, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

ONO-4641 · 1 trial · 1 indication

Phase 2 1
NCT01081782A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis
COMPLETED407 Analytics
PHASE2COMPLETED
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.
26 weeks

Secondary Endpoints

Total volume of Gd-enhanced lesions
26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
E1EXPERIMENTAL -
E2EXPERIMENTAL -
E3EXPERIMENTAL -
PPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ONO-4641DRUG0.15 mg once per day for 26 weeks
ONO-4641 placeboDRUGPlacebo once per day for 26 weeks
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites86

Inclusion Criteria: * Adult male or female aged 18-55 years inclusive at screening * Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis Exclusion Criteria: * Multiple Sclerosis course other than relapsing-remitting multiple sclerosis * History of malignancy * History...

Countries:United StatesBelgiumCanadaCzechiaGermanyGreeceJapanPolandRussiaSpainUkraine
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Frequently asked questions about ONO-4641

What is ONO-4641 used for?

ONO-4641 is an investigational small molecule being developed for the treatment of multiple sclerosis. It is currently in Phase 2 clinical development and is not approved by the FDA. The drug is being studied specifically in patients with relapsing-remitting multiple sclerosis.

Who makes ONO-4641?

ONO-4641 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in Phase 2 clinical development for multiple sclerosis and remains investigational.

What phase is ONO-4641 in?

ONO-4641 is in Phase 2 clinical development. It is an investigational drug for multiple sclerosis and has not been approved by the FDA. One Phase 2 trial has been completed, involving 407 patients with relapsing-remitting multiple sclerosis.

What clinical trials is ONO-4641 in?

ONO-4641 has one completed Phase 2 clinical trial, identified as NCT01081782. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ONO-4641 in 407 patients with relapsing-remitting multiple sclerosis across multiple countries.

Is ONO-4641 FDA approved?

ONO-4641 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for multiple sclerosis. The drug has completed one Phase 2 trial, but it remains in clinical development and has not received regulatory approval.