Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

PHASE3RecruitingINTERVENTIONAL
Enrollment

690

Participants

Timeline

Start Date

January 24, 2022

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2025

Conditions
Schizophrenia
Interventions
DRUG

Brilaroxazine

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.

OTHER

Placebo

RP5063 matching Placebo

Trial Locations (18)

20877

RECRUITING

Reviva site, Gaithersburg

30030

RECRUITING

Reviva site, Decatur

30331

RECRUITING

Reviva site, Atlanta

33016

RECRUITING

Reviva site, Miami Lakes

33021

RECRUITING

Reviva site, Hollywood

33024

RECRUITING

Reviva site, Hollywood

60641

RECRUITING

Reviva site, Chicago

72211

RECRUITING

Reviva site, Little Rock

72712

RECRUITING

Reviva site, Bentonville

72758

RECRUITING

Reviva site, Rogers

73112

RECRUITING

Reviva site, Oklahoma City

75080

RECRUITING

Reviva site, Richardson

78754

RECRUITING

Reviva site, Austin

85012

RECRUITING

Reviva site, Phoenix

92506

RECRUITING

Reviva site, Riverside

92845

RECRUITING

Reviva site, Garden Grove

92945

RECRUITING

Reviva site, Lemon Grove

02114

RECRUITING

Reviva site, Boston

Sponsors
All Listed Sponsors
lead

Reviva Pharmaceuticals

INDUSTRY