Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Launched by REVIVA PHARMACEUTICALS · Jan 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Brilaroxazine (RP5063) to see how effective and safe it is for people with schizophrenia, a mental health condition that can affect how a person thinks and feels. The study will compare Brilaroxazine to a placebo, which is a harmless substance that looks like the medication but has no active ingredients. Participants will take Brilaroxazine at doses of either 15 mg or 50 mg once a day for 4 weeks, followed by a longer period of up to 52 weeks where the dose may vary between 15 mg and 50 mg, depending on what works best for them.

To be eligible for the trial, participants must be between 18 and 65 years old and have a diagnosis of schizophrenia. People who have not responded to previous treatments or have other significant mental health issues may not be suitable for this study. Those who join can expect regular check-ins to monitor their health and any effects of the medication. It’s important to know that participants must not be taking certain medications or have specific medical histories that could interfere with the study. This trial is currently recruiting participants, so if you or someone you know has schizophrenia and is interested, it may be worth discussing this opportunity with a healthcare provider.

Gender

ALL

Eligibility 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.