Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension

ClinicalTrials.gov processed this data on February 13, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified February 2024 by Reviva Pharmaceuticals

Sponsor

Reviva Pharmaceuticals

Information Provided by (Responsible Party)

Reviva Pharmaceuticals

Clinicaltrials.gov Identifier

NCT05184335
Other Study ID Numbers: RVP-30-001 RECOVER
First Submitted: November 29, 2021
First Posted: January 11, 2022
Last Update Posted: February 14, 2024
Last Verified: February 2024
History of Changes

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Study Description

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).
Condition or Disease Intervention/Treatment
  • Schizophrenia
  • Drug: Brilaroxazine
  • Other: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment402 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitlePhase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension
Study Start DateJanuary 24, 2022
Anticipated Primary Completion DateOctober 31, 2024
Anticipated Study Completion DateOctober 31, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • RP5063 15 mg once daily
    • administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.
  • Drug: 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.
  • RP5063 (brilaroxazine) 50 mg once daily
    • administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks
  • Drug: 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.
  • Placebo
    • administered OD for 28 days.
  • Other: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Double Blind Safety and Efficacy of Brilaroxazine (RP5063) [28 days]
      decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28.
    2. Open label Safety and Efficacy of Brilaroxazine (RP5063) [52 weeks]
      (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])

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 65 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers Yes
    Inclusion Criteria
    • 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
    Exclusion Criteria
    • 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-na├»ve 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.

    Contacts and Locations

    Sponsors and Collaborators Reviva Pharmaceuticals
    Locations
    • Reviva site | Phoenix, Arizona, United States, 85012
    • Reviva site | Bentonville, Arkansas, United States, 72712
    • Reviva site | Little Rock, Arkansas, United States, 72211
    • Reviva site | Rogers, Arkansas, United States, 72758
    • Reviva site | Garden Grove, California, United States, 92845
    • Reviva site | Lemon Grove, California, United States, 92945
    • Reviva site | Riverside, California, United States, 92506
    • Reviva site | Hollywood, Florida, United States, 33021
    • Reviva site | Hollywood, Florida, United States, 33024
    • Reviva site | Miami Lakes, Florida, United States, 33016
    • Reviva site | Atlanta, Georgia, United States, 30331
    • Reviva site | Decatur, Georgia, United States, 30030
    • Reviva site | Chicago, Illinois, United States, 60641
    • Reviva site | Gaithersburg, Maryland, United States, 20877
    • Reviva site | Boston, Massachusetts, United States, 02114
    • Reviva site | Oklahoma City, Oklahoma, United States, 73112
    • Reviva site | Austin, Texas, United States, 78754
    • Reviva site | Richardson, Texas, United States, 75080
    Investigators

      More Information

      Additional Relevant MeSH Terms

      • Schizophrenia
      • Schizophrenia Spectrum and Other Psychotic Disorders
      • Mental Disorders