drugset / Trial / NCT05184335

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

NCT05184335

Phase 3 Recruiting 690 enrolled Reviva Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-01-24
Primary completion
2025-02
Completion
2025-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Brilaroxazine Small molecule 15 mg
Comparator Brilaroxazine Small molecule 30 mg
Comparator Brilaroxazine Small molecule 50 mg

Indications