Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2022/11/047063
- Lead Sponsor
- Reviva Pharmaceuticals Holdings Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
1)Has a history of treatment resistance exhibited by any of the following:
a) No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
b) Lifetime history of clozapine use
c) 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, Alzheimers 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 inhibitors, CNS stimulants, potent CYP3A4 or 5 enzyme-inducing drugs including but not limited to rifampin and carbamazepine and strong CYP3A4 or 5 inhibitors like ketoconazole, itraconazole, clarithromycin, etc.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Double Blind Safety and Efficacy of RP5063 (brilaroxazine) <br/ ><br>Decrease in Positive and Negative Symptoms Assessment (PANSS) total score compared to placebo from Baseline to Day 28 <br/ ><br>2) Open label Safety and Efficacy of RP5063 (brilaroxazine) <br/ ><br>RP5063 tablets (at flexible doses of 15 mg or 30 mg or 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])Timepoint: 1) Time Frame: 28 days <br/ ><br>2) Time Frame: 52 weeks
- Secondary Outcome Measures
Name Time Method CGI-S scale: Proportion of subjects with greater than or equals to 1-point improvement from Baseline to Day 28.Timepoint: Baseline to Day 28