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.

NCT05184335

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Reviva Pharmaceuticals
~690 participants
Updated 2024-12-19 on ClinicalTrials.gov
What's tested:BrilaroxazinePlacebo

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Double Blind Safety and Efficacy of Brilaroxazine (RP5063)
Measured over 28 days
+1 more outcome measured
Schizophrenia
18 sites across 10 states
Arkansas3
California3
Florida3
Georgia2
Texas2
Arizona1
Illinois1
Maryland1
  • Medical Director · STUDY_DIRECTOR · Reviva Pharma

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  • 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 \[Safety and Tolerability\])