CTRI/2022/11/047063 [Registered on: 04/11/2022] Trial Registered Prospectively
Last Modified On:
12/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Scientific Title of Study
Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension
Pharmaceutical Research Associates India Private Limited
Address
Level 3 and 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South
Pharmaceutical Research Associates India Private Limited
Address
Level 3 and 4, Prestige Blue Chip Software Park, Municipal No. 9, Hosur Road, Adugodi, Madiwala Range, Ward No. 63, Bangalore, Tavarekere, Bangalore South
Ethics Commitee Ratandeep Multi Speciality Hospital
Approved
Ethics Committee Shanti Nursing Home
Approved
Ethics Committee Vinaya Hospital
Approved
Ethics Committee, Radianz healthcare and research Ahana Hospitals
Approved
IEC JSS Medical College
Approved
Institutional Ethics Committee Sardarmal Khandaka Memorial Hospital
Approved
Institutional Ethics Committee, King George’s Medical University
Approved
Institutional Ethics Committee, Raja Rajeswari Medical College and Hospital
Approved
Institutional Ethics Committee, Shri Guru Ram Rai Institute of Medical & Health Science
Approved
Marudhar Hospital Ethics Committee
Approved
Rising Medicare Hospital and IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: F20||Schizophrenia,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Brilaroxazine (RP5063)
RP5063 (brilaroxazine) 15 mg once daily administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.
Intervention
Brilaroxazine (RP5063)
RP5063 (brilaroxazine) 50 mg once daily administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks
Comparator Agent
Placebo
Placebo administered OD for 28 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1) Double Blind Safety and Efficacy of RP5063 (brilaroxazine)
Decrease in Positive and Negative Symptoms Assessment (PANSS) total score compared to placebo from Baseline to Day 28
2) Open label Safety and Efficacy of RP5063 (brilaroxazine)
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])
1) Time Frame: 28 days
2) Time Frame: 52 weeks
Secondary Outcome
Outcome
TimePoints
CGI-S scale: Proportion of subjects with greater than or equals to 1-point improvement from Baseline to Day 28.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a randomized, Double
Blind (DB), placebo-controlled, multicenter study to assess the efficacy and
safety of RP5063 (brilaroxazine) at fixed doses of 15 mg or 50 mg, administered
Once Daily (OD) for 28 days (28 days DB treatment) in subjects with an acute
exacerbation of schizophrenia. The study further will assess the safety of
RP5063 (brilaroxazine) at flexible doses of either 15 or 30 or 50 mg
administered OD in an Open Label (OL) treatment over a period of 52 weeks
(52-week OL treatment part), in subjects with stable schizophrenia. The OL
treatment will have 2 populations of stable schizophrenia: DB rollover and de
novo subjects.
The study comprises 2 parts: a 28
days DB treatment; followed by 52 weeks OL treatment.
The total duration of the study is 56 weeks (28
days/4 weeks DB treatment and 52-weeks OL treatment).