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Clinical Trial Summary

This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily. The aim of this study is to also assess the long-term tolerability of these tablets over a period of 52 weeks.

Clinical Trial 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 or 30 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 days 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05184335
Study type Interventional
Source Reviva Pharmaceuticals
Contact Medical Director
Phone +1 4085018881
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date January 24, 2022
Completion date December 20, 2022

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