Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT05184335
- Run by
- Reviva Pharmaceuticals
- People needed
- 690
- Starts
- 2022-01-24
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2024-12-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Reviva site — Phoenix, Arizona, United States (enrolling)
- Reviva site — Bentonville, Arkansas, United States (enrolling)
- Reviva site — Little Rock, Arkansas, United States (enrolling)
- Reviva site — Rogers, Arkansas, United States (enrolling)
- Reviva site — Garden Grove, California, United States (enrolling)
- Reviva site — Lemon Grove, California, United States (enrolling)
- Reviva site — Riverside, California, United States (enrolling)
- Reviva site — Hollywood, Florida, United States (enrolling)
- Reviva site — Hollywood, Florida, United States (enrolling)
- Reviva site — Miami Lakes, Florida, United States (enrolling)
- Reviva site — Atlanta, Georgia, United States (enrolling)
- Reviva site — Decatur, Georgia, United States (enrolling)
- Reviva site — Chicago, Illinois, United States (enrolling)
- Reviva site — Gaithersburg, Maryland, United States (enrolling)
- Reviva site — Boston, Massachusetts, United States (enrolling)
- Reviva site — Oklahoma City, Oklahoma, United States (enrolling)
- Reviva site — Austin, Texas, United States (enrolling)
- Reviva site — Richardson, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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