RECRUITING

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-01-24
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05184335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is male or female, aged 18 to 65 years
  2. 2. 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
  3. 3. Diagnosis schizophrenia
  1. 1. Has a history of treatment resistance exhibited by any of the following:
  2. 1. No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
  3. 2. Lifetime history of clozapine use
  4. 3. History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
  5. 2. Is treatment-naïve for schizophrenia.
  6. 3. Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
  7. 4. Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
  8. 5. Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).
  9. 6. Has a history of the following: (a) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system (CNS) (b) intellectual disability of a severity that would impact ability to participate in the study.
  10. 7. Subject has a current primary DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, manic episode, hypomania, panic disorder, delirium, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
  11. 8. On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
  12. 9. Within 28 days prior to Baseline: monoamine oxidase (MAO) inhibitors, CNS stimulants, potent CYP3A4/5 enzyme-inducing drugs including but not limited to rifampin and carbamazepine and strong CYP3A4/5 inhibitors like ketoconazole, itraconazole, clarithromycin, etc. (see Appendix 20.1 for prohibited medications).
  13. 10. Antipsychotic depot medication within 5 half-lives prior to Baseline.
  14. 11. Positive Urine Drug Screen for drugs of abuse, including amphetamines, barbiturates, cocaine, ecstasy, phencyclidine or opiates meeting criteria of moderate-to-severe DSM-5 substance use disorder.

Contacts and Locations

Study Contact

Medical Director
CONTACT
+1 4085018881
medicaldirector@revivapharma.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Reviva Pharma

Study Locations (Sites)

Reviva site
Phoenix, Arizona, 85012
United States
Reviva site
Bentonville, Arkansas, 72712
United States
Reviva site
Little Rock, Arkansas, 72211
United States
Reviva site
Rogers, Arkansas, 72758
United States
Reviva site
Garden Grove, California, 92845
United States
Reviva site
Lemon Grove, California, 92945
United States
Reviva site
Riverside, California, 92506
United States
Reviva site
Hollywood, Florida, 33021
United States
Reviva site
Hollywood, Florida, 33024
United States
Reviva site
Miami Lakes, Florida, 33016
United States
Reviva site
Atlanta, Georgia, 30331
United States
Reviva site
Decatur, Georgia, 30030
United States
Reviva site
Chicago, Illinois, 60641
United States
Reviva site
Gaithersburg, Maryland, 20877
United States
Reviva site
Boston, Massachusetts, 02114
United States
Reviva site
Oklahoma City, Oklahoma, 73112
United States
Reviva site
Austin, Texas, 78754
United States
Reviva site
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Reviva Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Reviva Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2022-01-24
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia