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Serotonin-Dopamine Activity Modulator
Brilaroxazine for Schizophrenia (RECOVER Trial)
Phase 3
Recruiting
Research Sponsored by Reviva Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Summary
This trial tests Brilaroxazine, a daily pill, in patients with severe mental health issues. It aims to improve mood and reduce symptoms. The study lasts for more than a year.
Who is the study for?
Adults aged 18-65 with acute schizophrenia can join this trial. They must understand and sign a consent form, have not used certain antipsychotics recently or drugs that strongly affect the body's enzyme systems, and cannot have treatment-resistant schizophrenia, history of clozapine use, substance abuse disorders within the last six months, brain injuries affecting cognition, dementia or other CNS diseases.
What is being tested?
The study tests Brilaroxazine's safety and effectiveness against a placebo in treating acute schizophrenia. Participants will receive either 15 mg or 50 mg daily for one month followed by flexible dosing up to 52 weeks to see how well it works short-term and long-term.
What are the potential side effects?
Possible side effects of Brilaroxazine may include typical antipsychotic drug reactions such as drowsiness, restlessness (akathisia), weight gain, dry mouth, constipation, blurred vision or dizziness. Long-term effects are being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Double Blind Safety and Efficacy of Brilaroxazine (RP5063)
Open label Safety and Efficacy of Brilaroxazine (RP5063)
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: RP5063 15 mg once dailyActive Control1 Intervention
administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.
Group II: RP5063 (brilaroxazine) 50 mg once dailyActive Control1 Intervention
administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks
Group III: PlaceboPlacebo Group1 Intervention
administered OD for 28 days.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for schizophrenia include antipsychotic medications, which primarily function by modulating neurotransmitter activity in the brain. First-generation antipsychotics (FGAs) mainly block dopamine D2 receptors, reducing dopamine activity to alleviate psychotic symptoms.
Second-generation antipsychotics (SGAs) or atypical antipsychotics, such as risperidone, quetiapine, and olanzapine, not only block dopamine D2 receptors but also affect serotonin receptors, particularly 5-HT2A receptors. This dual action helps in managing both positive symptoms (like hallucinations and delusions) and negative symptoms (such as social withdrawal and apathy) of schizophrenia.
Brilaroxazine, a serotonin-dopamine modulator, aims to balance serotonin and dopamine activity more precisely, potentially offering improved efficacy and reduced side effects. Understanding these mechanisms is crucial for schizophrenia patients as it informs the choice of medication that can best manage their symptoms with the least adverse effects.
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Who is running the clinical trial?
Reviva PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
246 Total Patients Enrolled
1 Trials studying Schizophrenia
234 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorReviva Pharma
2,834 Previous Clinical Trials
8,079,378 Total Patients Enrolled
28 Trials studying Schizophrenia
3,936 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia.I have a psychotic disorder not including schizophrenia, or behavior issues from substance abuse.I have had ECT for schizophrenia in the last 5 years.I have never received treatment for schizophrenia.I have a brain condition affecting my thinking or memory that may impact my study participation.My condition did not improve after two long treatments with the strongest doses of antipsychotic medication.I have used clozapine at some point in my life.My main diagnosis isn't schizophrenia, but another condition causing my symptoms.I haven't taken long-lasting antipsychotic medication recently.I haven't taken specific strong medications or stimulants in the last 28 days.I have a mental health condition, but it's not schizophrenia.I am between 18 and 65 years old.I have been taking antipsychotic medication for at least 3 days before the study starts and will continue throughout.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: RP5063 15 mg once daily
- Group 3: RP5063 (brilaroxazine) 50 mg once daily
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05184335 — Phase 3
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