Brilaroxazine for Schizophrenia
This study is testing a new medication called Brilaroxazine (RP5063) for people with schizophrenia. Researchers want to see how safe and effective Brilaroxazine is compared to a placebo (a pill with no medicine) in both the short-term (4 weeks) and long-term (52 weeks). Brilaroxazine is a new drug that has not yet been approved for use. You might be able to join if you are 18 to 65 years old, have a diagnosis of schizophrenia, and meet other specific health requirements. The study aims to understand if Brilaroxazine can help manage symptoms of schizophrenia. The current status of this study is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study involving up to 690 participants. It compares Brilaroxazine at fixed doses (15 mg or 50 mg) to a placebo for 28 days, followed by a 52-week open-label treatment period with flexible doses (15, 30, or 50 mg).
- What's involved
- Participants will receive Brilaroxazine or a placebo daily for 28 days, followed by daily Brilaroxazine for 52 weeks. The total study duration is 56 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures safety and effectiveness for 28 days (double-blind) and then for 52 weeks (open-label).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
At a glance
Conditions
Where it's being run
18 sites across 10 statesStudy leadership
- Medical Director · STUDY_DIRECTOR · Reviva Pharma
Who to contact
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What this trial measures
- Double Blind Safety and Efficacy of Brilaroxazine (RP5063)28 days
decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28.
- Open label Safety and Efficacy of Brilaroxazine (RP5063)52 weeks
(brilaroxazine) tablets (at flexible doses of 15 mg or 30 mg 0r 50mg OD) in an treatment part over a period of 52 weeks in stable schizophrenia subjects. The endpoints would be incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\])