Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

NCT05184335 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RVP-30-001 RECOVER
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Double Blind Safety and Efficacy of Brilaroxazine (RP5063)

  decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28.

  28 days

• Open label Safety and Efficacy of Brilaroxazine (RP5063)

  (brilaroxazine) tablets (at flexible doses of 15 mg or 30 mg 0r 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 \[Safety and Tolerability\])

  52 weeks

Study Arms (3)

RP5063 15 mg once daily

ACTIVE COMPARATOR

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

Drug: Brilaroxazine

RP5063 (brilaroxazine) 50 mg once daily

ACTIVE COMPARATOR

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

Drug: Brilaroxazine

Placebo

PLACEBO COMPARATOR

administered OD for 28 days.

Other: Placebo

Interventions

Brilaroxazine 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.

Also known as: RP5063

RP5063 (brilaroxazine) 50 mg once daily; RP5063 15 mg once daily

Placebo OTHER

RP5063 matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female, aged 18 to 65 years
• 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
• Diagnosis schizophrenia

You may not qualify if:

• Has a history of treatment resistance exhibited by any of the following:
• No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
• Lifetime history of clozapine use
• History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
• Is treatment-naïve for schizophrenia.
• Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
• Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
• Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).
• 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.
• 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.
• On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
• 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).
• Antipsychotic depot medication within 5 half-lives prior to Baseline.
• 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.

Sponsors & Collaborators

• Reviva Pharmaceuticals: lead

Study Sites (18)

Reviva site

Phoenix, Arizona, 85012, United States

RECRUITING

Reviva site

Bentonville, Arkansas, 72712, United States

RECRUITING

Reviva site

Little Rock, Arkansas, 72211, United States

RECRUITING

Reviva site

Rogers, Arkansas, 72758, United States

RECRUITING

Reviva site

Garden Grove, California, 92845, United States

RECRUITING

Reviva site

Lemon Grove, California, 92945, United States

RECRUITING

Reviva site

Riverside, California, 92506, United States

RECRUITING

Reviva site

Hollywood, Florida, 33021, United States

RECRUITING

Reviva site

Hollywood, Florida, 33024, United States

RECRUITING

Reviva site

Miami Lakes, Florida, 33016, United States

RECRUITING

Reviva site

Atlanta, Georgia, 30331, United States

RECRUITING

Reviva site

Decatur, Georgia, 30030, United States

RECRUITING

Reviva site

Chicago, Illinois, 60641, United States

RECRUITING

Reviva site

Gaithersburg, Maryland, 20877, United States

RECRUITING

Reviva site

Boston, Massachusetts, 02114, United States

RECRUITING

Reviva site

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Reviva site

Austin, Texas, 78754, United States

RECRUITING

Reviva site

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

RP5063

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Director

  Reviva Pharma

  STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

+1 4085018881; medicaldirector@revivapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 11, 2022
• Study Start: January 24, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

US (18)