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NCT05184335 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Reviva Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 690
- Enrollment target
- 18
- Study locations
NCT05184335: Recruiting Phase 3 study of Schizophrenia, sponsored by Reviva Pharmaceuticals.
NCT05184335 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Reviva Pharmaceuticals. The registered enrollment target is 690 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (218% higher). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05184335, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Reviva Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 690 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
decrease in Positive and Negative Symptoms Assessment total score compared to placebo from Baseline to Day 28.
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 |
What NCT05184335 shows while recruiting
NCT05184335 is an interventional study that assigns participants to a tested intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (218% higher).
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.
NCT05184335 lists 18 locations in 10 states (Arkansas, California, Florida).
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.
What interventions are being tested in trial NCT05184335?
The interventions under investigation include: Placebo (OTHER), Brilaroxazine (DRUG).
Who is sponsoring clinical trial NCT05184335?
This trial is sponsored by Reviva Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05184335's enrollment target sits among peer trials
690 20th of 315 higher than 296 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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