Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2025-02-28

Brief Summary

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This study is to evaluate the effect and safety of Brilaroxazine in patients with acute schizophrenia compared to the placebo short and long-term. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily over 4 weeks, then in the long-term flexible doses 15-50mg daily over a period of 52 weeks.

Detailed Description

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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, 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-day 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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel group efficacy and safety study with 3 treatment arms (2 active, one placebo, randomized 1:1:1) that is blinded for participants and involved study staff except dedicated unblinded individuals in statistics and drug safety. The OLE part will provide RP5063 15 mg, 30mg or 50mg OD open label to all participants.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RP5063 15 mg once daily

administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.

Group Type ACTIVE_COMPARATOR

Brilaroxazine

Intervention Type DRUG

RP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.

RP5063 (brilaroxazine) 50 mg once daily

administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks

Group Type ACTIVE_COMPARATOR

Brilaroxazine

Intervention Type DRUG

RP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.

Placebo

administered OD for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

RP5063 matching Placebo

Interventions

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Brilaroxazine

RP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.

Intervention Type DRUG

Placebo

RP5063 matching Placebo

Intervention Type OTHER

Other Intervention Names

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RP5063

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Reviva Pharma

Identifier Type: -

Identifier Source: org_study_id

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

RP5063 15 mg once daily

Brilaroxazine

RP5063 (brilaroxazine) 50 mg once daily

Brilaroxazine

Placebo

Placebo

Interventions

Brilaroxazine

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Reviva Pharmaceuticals

Responsible Party

Principal Investigators

Medical Director

Locations

Reviva site

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Countries

Central Contacts

Medical Director

Facility Contacts

Coordinator

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Other Identifiers

RVP-30-001 RECOVER