NCT05184335

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 690 (estimated)
• Sponsor: Reviva Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind (DB), placebo-controlled, multicenter study to assess the efficacy and safety of RP5063 (brilaroxazine) at fixed doses of 15 mg or 50 mg, administered once daily (OD) for 28 days (28 days DB treatment) in subjects with an acute exacerbation of schizophrenia. The study further will assess the safety of RP5063 (brilaroxazine) at flexible doses of either 15, 30 or 50 mg administered OD in an Open Label (OL) treatment over a period of 52 weeks (52-week OL treatment part), in subjects with stable schizophrenia. The OL treatment will have 2 populations of stable schizophrenia: DB rollover and de novo subjects. The study comprises 2 parts: a 28-day DB treatment, followed by 52 weeks OL treatment. The total duration of the study is 56 weeks (28 days/4 weeks DB treatment and 52-weeks OL treatment).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-24
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2022-01-11
• Last updated: 2024-12-19

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study