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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 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.

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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.

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

FieldValue
Enrollment Target 690 participants
Start Date 2022-01-24
Est. Completion 2025-02
Phase Phase 3

Sponsor

Reviva Pharmaceuticals

2 total trials

What the Registry Record Tells You About NCT05184335

The ClinicalTrials.gov registry entry for NCT05184335 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 690 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (218% higher). The listed sponsor is Reviva Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.