SchizophreniaPhase 3RECOVERNCT05184335
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
A Phase 3 study testing Brilaroxazine in people with Schizophrenia, run by Reviva Pharmaceuticals at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brilaroxazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 690 participants
- Where
- 18 sitesUnited States
- Study dates
- 24 Jan 2022to Feb 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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-naïve for schizophrenia.
- Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
Show all 14Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Reviva site
Atlanta, Georgia, 30331
Coordinator
- Recruiting
Reviva site
Austin, Texas, 78754
Coordinator
- Recruiting
Reviva site
Bentonville, Arkansas, 72712
Coordinator
- Recruiting
Reviva site
Boston, Massachusetts, 02114
Coordinator
- Recruiting
Reviva site
Chicago, Illinois, 60641
Coordinator
- Recruiting
Reviva site
Decatur, Georgia, 30030
Coordinator
- Recruiting
Reviva site
Gaithersburg, Maryland, 20877
Coordinator
- Recruiting
Reviva site
Garden Grove, California, 92845
Coordinator
- Recruiting
Reviva site
Hollywood, Florida, 33021
Coordinator
- Recruiting
Reviva site
Hollywood, Florida, 33024
Coordinator
- Recruiting
Reviva site
Lemon Grove, California, 92945
Coordinator
- Recruiting
Reviva site
Little Rock, Arkansas, 72211
Coordinator
- Recruiting
Reviva site
Miami Lakes, Florida, 33016
Coordinator
- Recruiting
Reviva site
Oklahoma City, Oklahoma, 73112
Coordinator
- Recruiting
Reviva site
Phoenix, Arizona, 85012
Coordinator
- Recruiting
Reviva site
Richardson, Texas, 75080
Coordinator
- Recruiting
Reviva site
Riverside, California, 92506
Coordinator
- Recruiting
Reviva site
Rogers, Arkansas, 72758
Coordinator
About this study
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
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.
Read the 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).
- Conditions
- Schizophrenia
- Being tested
- Brilaroxazine, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrilaroxazineDrug
Also called RP5063
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.
PlaceboOther
RP5063 matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| RP5063 15 mg once daily | Active comparator | administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks. Receives: Drug: Brilaroxazine |
| RP5063 (brilaroxazine) 50 mg once daily | Active comparator | administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks Receives: Drug: Brilaroxazine |
| Placebo | Placebo comparator | administered OD for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Blind Safety and Efficacy of Brilaroxazine (RP5063)
decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28.
Measured: 28 days
Open label Safety and Efficacy of Brilaroxazine (RP5063)
(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])
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start24 Jan 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reviva Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Reviva Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184335
- Sponsor's protocol ID
- RVP-30-001 RECOVER
- Acronym
- RECOVER
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cohen AS, Kirkpatrick B, Opler M, Tatsumi K, Bhat S, Bhat L. A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials. Biol Psychiatry. 2026 Jul 15;100(2):160-169. doi: 10.1016/j.biopsych.2025.11.025. Epub 2025 Dec 17.
PubMed 41419191
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05184335
- Acronym / sponsor ID
- RECOVER / RVP-30-001 RECOVER
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Reviva PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| RP5063 15 mg once daily | Active comparator | Drug: Brilaroxazineadministered OD for 28 days then flexibly 15-50mg over a period of 52 weeks. |
| RP5063 (brilaroxazine) 50 mg once daily | Active comparator | Drug: Brilaroxazineadministered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks |
| Placebo | Placebo comparator | Other: Placeboadministered OD for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Has a history of treatment resistance exhibited by any of the following:
- Is treatment-naïve 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrilaroxazineAlso: RP5063RP5063, 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. | Drug | RP5063 (brilaroxazine) 50 mg once daily, RP5063 15 mg once daily |
| PlaceboRP5063 matching Placebo | Other | Placebo |
Primary outcome
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])
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 41419191Cohen AS, Kirkpatrick B, Opler M, Tatsumi K, Bhat S, Bhat L. A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials. Biol Psychiatry. 2026 Jul 15;100(2):160-169. doi: 10.1016/j.biopsych.2025.11.025. Epub 2025 Dec 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Reviva Pharma
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brilaroxazine in people with Schizophrenia, run by Reviva Pharmaceuticals at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+1 4085018881, medicaldirector@revivapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double Blind Safety and Efficacy of Brilaroxazine (RP5063) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.