NCT05184335 · Reviva Pharmaceuticals
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
(RECOVER)
What this study is about
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.
View original scientific description
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.
Interventions
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
Placebo
RP5063 matching Placebo
Primary outcome measures
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.
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 \[Safety and Tolerability\])
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Phoenix, Arizona
- Bentonville, Arkansas
- Little Rock, Arkansas
- Rogers, Arkansas
- Garden Grove, California
- Lemon Grove, California
- Riverside, California
- Hollywood, Florida
- Miami Lakes, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Chicago, Illinois
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2024 · Source of record for eligibility and locations