Phase 3 Study to Evaluate the Safety and Effectiveness of Brilaroxazine in Adults With Schizophrenia 28-Day Double-Blind Treatment Followed by 52-Week Open-Label Extension

What this Trial Is About

Researchers are evaluating the safety and effect of Brilaroxazine in adults aged 18 to 65 with acute schizophrenia. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare fixed doses of Brilaroxazine to placebo over a short-term period and to assess its long-term safety in stable schizophrenia. The research is sponsored by Reviva Pharmaceuticals and includes both initial treatment and extended observation phases. Participants receive either 15 mg or 50 mg of Brilaroxazine once daily for 28 days under double-blind conditions, or a matching placebo. This is followed by an open-label phase lasting 52 weeks where doses of Brilaroxazine are flexibly adjusted between 15 mg and 50 mg daily. The long-term phase includes subjects who completed the initial double-blind treatment and new participants with stable schizophrenia. Throughout the 56-week study, participants undergo regular assessments to monitor safety and effectiveness. Researchers measure outcomes during the initial 28 days and the subsequent 52-week open-label period. The study includes various evaluations, including safety monitoring and symptom assessments, to gather comprehensive data on Brilaroxazines impact during both acute and stable phases of schizophrenia treatment.

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia