Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia (RECOVER)

December 16, 2024 updated by: Reviva Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

690

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other Names:
  • RP5063
Active Comparator: 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.
Other Names:
  • RP5063
Placebo Comparator: Placebo
administered OD for 28 days.
Other: Placebo
RP5063 matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double Blind Safety and Efficacy of Brilaroxazine (RP5063)
Time Frame: 28 days
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)
Time Frame: 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])
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reviva Pharmaceuticals

Investigators

  • Study Director: Medical Director, Reviva Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVP-30-001 RECOVER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe