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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
Diagnosis schizophrenia
Subject is male or female, aged 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

RECOVER Trial Summary

This trial is to see if the drug Brilaroxazine is effective and safe for patients with acute schizophrenia compared to a placebo, over the short and long term.

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.Check my eligibility
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.See study design
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.

RECOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia.
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with schizophrenia.
Select...
I am between 18 and 65 years old.

RECOVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double Blind Safety and Efficacy of Brilaroxazine (RP5063)
Open label Safety and Efficacy of Brilaroxazine (RP5063)

RECOVER 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.

Find a Location

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
2,770 Previous Clinical Trials
8,061,724 Total Patients Enrolled
28 Trials studying Schizophrenia
3,936 Patients Enrolled for Schizophrenia

Media Library

Brilaroxazine (Serotonin-Dopamine Activity Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05184335 — Phase 3
Schizophrenia Research Study Groups: RP5063 15 mg once daily, RP5063 (brilaroxazine) 50 mg once daily, Placebo
Schizophrenia Clinical Trial 2023: Brilaroxazine Highlights & Side Effects. Trial Name: NCT05184335 — Phase 3
Brilaroxazine (Serotonin-Dopamine Activity Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05184335 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05184335 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we looking for more participants in this experiment?

"The study is still recruiting patients, as evidenced by the listing on clinicaltrials.gov. The trial was first posted on January 24th, 2022 and has been edited most recently on April 1st, 2022."

Answered by AI

Is the age limit for participants in this research project set at 50 years or younger?

"The age requirement to participate in this trial is between 18-65 years old. There are 47 other trials available for patients under the age of eighteen and 174 options for those over sixty-five."

Answered by AI

Are there any harmful interactions associated with taking RP5063 (brilaroxazine) 50 mg daily?

"RP5063 (brilaroxazine) 50 mg once daily has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, which provides some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

In how many places is this trial currently taking place?

"To make things more convenient for potential participants, this trial is being run out of 17 different sites. These locations include Bentonville, Garden Grove and Little Rock as well as 14 other cities."

Answered by AI

How many people can join this trial at most?

"Yes, the clinical trial is still looking for patients. The study was originally posted on January 24th, 2022 and updated most recently on April 1st of the same year. They are recruiting 402 individuals from 17 hospitals or clinics."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Illinois
How old are they?
18 - 65
What site did they apply to?
Other
Reviva site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
Iam a Schizophrenia patient suffering since 16 years and I want to involve in Brilaroxazine trial from India.
PatientReceived 2+ prior treatments
~85 spots leftby Oct 2024