๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-12-16

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia (NCT05184335)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Reviva Pharmaceuticals

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Reviva site โ€” Phoenix, Arizona

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • Reviva site โ€” Phoenix, Arizona
  • Reviva site โ€” Bentonville, Arkansas
  • Reviva site โ€” Little Rock, Arkansas
  • Reviva site โ€” Rogers, Arkansas
  • Reviva site โ€” Garden Grove, California
  • Reviva site โ€” Lemon Grove, California
  • Reviva site โ€” Riverside, California
  • Reviva site โ€” Hollywood, Florida
  • Reviva site โ€” Hollywood, Florida
  • Reviva site โ€” Miami Lakes, Florida
  • Reviva site โ€” Atlanta, Georgia
  • Reviva site โ€” Decatur, Georgia
  • Reviva site โ€” Chicago, Illinois
  • Reviva site โ€” Gaithersburg, Maryland
  • Reviva site โ€” Boston, Massachusetts
  • Reviva site โ€” Oklahoma City, Oklahoma
  • Reviva site โ€” Austin, Texas
  • Reviva site โ€” Richardson, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (408) 501-8881

Email: medicaldirector@revivapharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Schizophrenia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—