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Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
NCT05184335 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Brilaroxazine
Study Locations (18)
Arkansas
- Reviva site — Bentonville
- Reviva site — Little Rock
- Reviva site — Rogers
California
- Reviva site — Garden Grove
- Reviva site — Lemon Grove
- Reviva site — Riverside
Florida
- Reviva site — Hollywood
- Reviva site — Hollywood
- Reviva site — Miami Lakes
Georgia
- Reviva site — Atlanta
- Reviva site — Decatur
Texas
- Reviva site — Austin
- Reviva site — Richardson
Arizona
- Reviva site — Phoenix
Illinois
- Reviva site — Chicago
Maryland
- Reviva site — Gaithersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2025-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05184335
The ClinicalTrials.gov registry entry for NCT05184335 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 690 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reviva Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05184335 reports 18 study locations spanning 10 distinct geographic areas — top geographies include Arkansas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05184335 about?
NCT05184335 is a clinical study titled "Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia". 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...
What is the current status of trial NCT05184335?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2022-01-24. Estimated completion is 2025-02.
What conditions does trial NCT05184335 study?
This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05184335?
The interventions under investigation include: Placebo (OTHER), Brilaroxazine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05184335?
This trial is sponsored by Reviva Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05184335 being conducted?
This trial has 18 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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