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Tests treatment safety and results for Schizophrenia
Official title Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
ClinicalTrials.gov ID: NCT05184335
What this study is testing
What is Brilaroxazine?
Brilaroxazine is an investigational medicine, given as an once-daily, being studied as a potential treatment for schizophrenia.
Also referred to as RP5063.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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...
- Diagnosis schizophrenia
You likely can't join 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...
See the full eligibility criteria
- 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
- 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)...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Garden Grove, California, United States
- Lemon Grove, California, United States
- Riverside, California, United States
- Hollywood, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Gaithersburg, Maryland, United States
- Boston, Massachusetts, United States
- Oklahoma City, Oklahoma, United States
- Austin, Texas, United States
- Richardson, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Garden Grove, California, United States; Lemon Grove, California, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.