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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Subject is male or female, aged 18 to 65 years
• Subject reads, understands, and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved current ICF prior to performing any of the Screening procedures
• Diagnosis schizophrenia
Locations
United States
Arkansas
Reviva site
RECRUITING
Bentonville
Reviva site
RECRUITING
Little Rock
Reviva site
RECRUITING
Rogers
Arizona
Reviva site
RECRUITING
Phoenix
California
Reviva site
RECRUITING
Garden Grove
Reviva site
RECRUITING
Lemon Grove
Reviva site
RECRUITING
Riverside
Florida
Reviva site
RECRUITING
Hollywood
Reviva site
RECRUITING
Hollywood
Reviva site
RECRUITING
Miami Lakes
Georgia
Reviva site
RECRUITING
Atlanta
Reviva site
RECRUITING
Decatur
Illinois
Reviva site
RECRUITING
Chicago
Massachusetts
Reviva site
RECRUITING
Boston
Maryland
Reviva site
RECRUITING
Gaithersburg
Oklahoma
Reviva site
RECRUITING
Oklahoma City
Texas
Reviva site
RECRUITING
Austin
Reviva site
RECRUITING
Richardson
Contact Information
Primary
Medical Director
medicaldirector@revivapharma.com
+1 4085018881
Time Frame
Start Date: 2022-01-24
Estimated Completion Date: 2025-02
Participants
Target number of participants: 690
Treatments
Active_comparator: RP5063 15 mg once daily
administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.
Active_comparator: RP5063 (brilaroxazine) 50 mg once daily
administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks
Placebo_comparator: Placebo
administered OD for 28 days.
Related Therapeutic Areas
Sponsors
Leads: Reviva Pharmaceuticals