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

Sponsor
Reviva Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05184335
Collaborator
(none)
402
Enrollment
18
Locations
3
Arms
22.8
Anticipated Duration (Months)
22.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 0r 30mg 0r 50mg OD open label to all participants.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 0r 30mg 0r 50mg OD open label to all participants.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

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

    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

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    2. No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.

    3. Lifetime history of clozapine use

    4. History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.

    5. Is treatment-naïve for schizophrenia.

    6. Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.

    7. Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.

    8. Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).

    9. 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.

    10. 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.

    11. On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).

    12. 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).

    13. Antipsychotic depot medication within 5 half-lives prior to Baseline.

    14. 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

    Locations

    Site City State Country Postal Code
    1 Reviva site Phoenix Arizona United States 85012
    2 Reviva site Bentonville Arkansas United States 72712
    3 Reviva site Little Rock Arkansas United States 72211
    4 Reviva site Rogers Arkansas United States 72758
    5 Reviva site Garden Grove California United States 92845
    6 Reviva site Lemon Grove California United States 92945
    7 Reviva site Riverside California United States 92506
    8 Reviva site Hollywood Florida United States 33021
    9 Reviva site Hollywood Florida United States 33024
    10 Reviva site Miami Lakes Florida United States 33016
    11 Reviva site Atlanta Georgia United States 30331
    12 Reviva site Decatur Georgia United States 30030
    13 Reviva site Chicago Illinois United States 60641
    14 Reviva site Gaithersburg Maryland United States 20877
    15 Reviva site Boston Massachusetts United States 02114
    16 Reviva site Oklahoma City Oklahoma United States 73112
    17 Reviva site Austin Texas United States 78754
    18 Reviva site Richardson Texas United States 75080

    Sponsors and Collaborators

    • Reviva Pharmaceuticals

    Investigators

    • Study Director: Medical Director, Reviva Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reviva Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05184335
    Other Study ID Numbers:
    • RVP-30-001 RECOVER
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Schizophrenia
    RP5063

    Study Results

    No Results Posted as of Apr 11, 2022