RecruitingPhase 3NCT05184335

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension


Sponsor

Reviva Pharmaceuticals

Enrollment

690 participants

Start Date

Jan 24, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo short and long-term. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily over 4 weeks, then in the long-term flexible doses 15-50mg daily over a period of 52 weeks.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and effectiveness of a new medication called brilaroxazine (RP5063) for treating schizophrenia in adults who have not been considered treatment-resistant. **You may be eligible if:** - You are between 18 and 65 years old - You have been diagnosed with schizophrenia - You have previously responded to antipsychotic medications - You are able to understand and sign an informed consent form **You may NOT be eligible if:** - You have never been treated for schizophrenia before - You have failed to respond to at least 2 different antipsychotic medications - You have a history of using clozapine - You have received electroconvulsive therapy (ECT) for schizophrenia in the past 5 years - You have another primary psychiatric diagnosis (such as major depression, bipolar disorder, or schizoaffective disorder) - You have a significant substance use disorder (other than caffeine or nicotine) in the past 6 months - You have a history of traumatic brain injury, Alzheimer's disease, or significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrilaroxazine

RP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.

OTHERPlacebo

RP5063 matching Placebo


Locations(18)

Reviva site

Phoenix, Arizona, United States

Reviva site

Bentonville, Arkansas, United States

Reviva site

Little Rock, Arkansas, United States

Reviva site

Rogers, Arkansas, United States

Reviva site

Garden Grove, California, United States

Reviva site

Lemon Grove, California, United States

Reviva site

Riverside, California, United States

Reviva site

Hollywood, Florida, United States

Reviva site

Hollywood, Florida, United States

Reviva site

Miami Lakes, Florida, United States

Reviva site

Atlanta, Georgia, United States

Reviva site

Decatur, Georgia, United States

Reviva site

Chicago, Illinois, United States

Reviva site

Gaithersburg, Maryland, United States

Reviva site

Boston, Massachusetts, United States

Reviva site

Oklahoma City, Oklahoma, United States

Reviva site

Austin, Texas, United States

Reviva site

Richardson, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05184335


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