Status:
RECRUITING
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Lead Sponsor:
Reviva Pharmaceuticals
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 o...
Detailed Description
This is a randomized, double-blind (DB), placebo-controlled, multicenter study to assess the efficacy and safety of RP5063 (brilaroxazine) at fixed doses of 15 mg or 50 mg, administered once daily (OD...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Has a history of treatment resistance exhibited by any of the following:
- No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
- Lifetime history of clozapine use
- History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
- Is treatment-naïve for schizophrenia.
- Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
- Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
- Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).
- 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.
- 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.
- On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
- 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).
- Antipsychotic depot medication within 5 half-lives prior to Baseline.
- 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.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT05184335
Start Date
January 24 2022
End Date
February 1 2025
Last Update
December 19 2024
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Reviva site
Phoenix, Arizona, United States, 85012
2
Reviva site
Bentonville, Arkansas, United States, 72712
3
Reviva site
Little Rock, Arkansas, United States, 72211
4
Reviva site
Rogers, Arkansas, United States, 72758