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Evaluating Brilaroxazine for treating schizophrenia

Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension

Phase 3 Interventional Reviva Pharmaceuticals · NCT05184335

This study is testing a new medication called Brilaroxazine to see if it can help people with acute schizophrenia feel better over a period of 56 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment690 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorReviva Pharmaceuticals Industry-sponsored
Locations18 sites (Phoenix, Arizona and 17 other locations)
Trial IDNCT05184335 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Brilaroxazine (RP5063) in patients experiencing acute schizophrenia. Participants will receive either Brilaroxazine at fixed doses of 15 mg or 50 mg once daily for 28 days, followed by a long-term open-label treatment phase lasting 52 weeks with flexible dosing. The study is randomized and double-blind, comparing the effects of the medication against a placebo. The total duration of the study is 56 weeks, encompassing both the short-term and long-term treatment phases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with schizophrenia experiencing an acute exacerbation.

Not a fit: Patients who are treatment-naïve or have a history of treatment resistance may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with schizophrenia.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of Brilaroxazine in this context is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject is male or female, aged 18 to 65 years
2. Subject reads, understands, and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved current ICF prior to performing any of the Screening procedures
3. Diagnosis schizophrenia

Exclusion Criteria:

1. Has a history of treatment resistance exhibited by any of the following:

   1. No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
   2. Lifetime history of clozapine use
   3. History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
2. Is treatment-naïve for schizophrenia.
3. Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
4. Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
5. Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).
6. Has a history of the following: (a) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system (CNS) (b) intellectual disability of a severity that would impact ability to participate in the study.
7. Subject has a current primary DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, manic episode, hypomania, panic disorder, delirium, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
8. On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
9. Within 28 days prior to Baseline: monoamine oxidase (MAO) inhibitors, CNS stimulants, potent CYP3A4/5 enzyme-inducing drugs including but not limited to rifampin and carbamazepine and strong CYP3A4/5 inhibitors like ketoconazole, itraconazole, clarithromycin, etc. (see Appendix 20.1 for prohibited medications).
10. Antipsychotic depot medication within 5 half-lives prior to Baseline.
11. Positive Urine Drug Screen for drugs of abuse, including amphetamines, barbiturates, cocaine, ecstasy, phencyclidine or opiates meeting criteria of moderate-to-severe DSM-5 substance use disorder.

Where this trial is running

Phoenix, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.