Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Public ClinicalTrials.gov record NCT05184335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05184335
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 690 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2022
- Primary completion
- Jan 31, 2025
- Completion
- Jan 31, 2025
- Last update posted
- Dec 18, 2024
2022 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Reviva site | Phoenix | Arizona | 85012 | Recruiting |
| Reviva site | Bentonville | Arkansas | 72712 | Recruiting |
| Reviva site | Little Rock | Arkansas | 72211 | Recruiting |
| Reviva site | Rogers | Arkansas | 72758 | Recruiting |
| Reviva site | Garden Grove | California | 92845 | Recruiting |
| Reviva site | Lemon Grove | California | 92945 | Recruiting |
| Reviva site | Riverside | California | 92506 | Recruiting |
| Reviva site | Hollywood | Florida | 33021 | Recruiting |
| Reviva site | Hollywood | Florida | 33024 | Recruiting |
| Reviva site | Miami Lakes | Florida | 33016 | Recruiting |
| Reviva site | Atlanta | Georgia | 30331 | Recruiting |
| Reviva site | Decatur | Georgia | 30030 | Recruiting |
| Reviva site | Chicago | Illinois | 60641 | Recruiting |
| Reviva site | Gaithersburg | Maryland | 20877 | Recruiting |
| Reviva site | Boston | Massachusetts | 02114 | Recruiting |
| Reviva site | Oklahoma City | Oklahoma | 73112 | Recruiting |
| Reviva site | Austin | Texas | 78754 | Recruiting |
| Reviva site | Richardson | Texas | 75080 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05184335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05184335 live on ClinicalTrials.gov.