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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
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: 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 Design

Phase
Phase 3
Study Type
Interventional
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, 30mg or 50mg OD open label to all participants.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Reviva site
Phoenix, Arizona 85012
Contact:
Coordinator

Reviva site
Bentonville, Arkansas 72712
Contact:
Coordinator

Reviva site
Little Rock, Arkansas 72211
Contact:
Coordinator

Reviva site
Rogers, Arkansas 72758
Contact:
Coordinator

Reviva site
Garden Grove, California 92845
Contact:
Coordinator

Reviva site
Lemon Grove, California 92945
Contact:
Coordinator

Reviva site
Riverside, California 92506
Contact:
Coordinator

Reviva site
Hollywood, Florida 33021
Contact:
Coordinator

Reviva site
Hollywood, Florida 33024
Contact:
Coordinator

Reviva site
Miami Lakes, Florida 33016
Contact:
Coordinator

Reviva site
Atlanta, Georgia 30331
Contact:
Coordinator

Reviva site
Decatur, Georgia 30030
Contact:
Coordinator

Reviva site
Chicago, Illinois 60641
Contact:
Coordinator

Reviva site
Gaithersburg, Maryland 20877
Contact:
Coordinator

Reviva site
Boston, Massachusetts 02114
Contact:
Coordinator

Reviva site
Oklahoma City, Oklahoma 73112
Contact:
Coordinator

Reviva site
Austin, Texas 78754
Contact:
Coordinator

Reviva site
Richardson, Texas 75080
Contact:
Coordinator

More Details

Status
Recruiting
Sponsor
Reviva Pharmaceuticals

Study Contact

Medical Director
+1 4085018881
medicaldirector@revivapharma.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.