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RO6889450 for Schizophrenia

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks)
Awards & highlights

Study Summary

This trial is testing a new medication for people with schizophrenia or schizoaffective disorder to see if it can improve negative symptoms.

Eligible Conditions
  • Schizophrenia, Schizoaffective Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-defined intervals from day 7 through the end of the follow-up period (approximately 16 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
Apathy
Secondary outcome measures
Area Under the Curve at Steady State (AUCss) of RO6889450
CGI-I Negative Symptoms Scores
Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores
+11 more

Side effects data

From 2022 Phase 2 trial • 287 Patients • NCT04512066
6%
Headache
5%
Insomnia
5%
Anxiety
3%
Schizophrenia
3%
Weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RO6889450 45 mg (Double-blind Treatment Period)
RO6889450 150 mg (Double-blind Treatment Period)
Risperidone 4 mg (Double-blind Treatment Period)
Placebo - RO6889450 45 mg
Placebo - RO6889450 150 mg
RO6889450 45 mg (Extension Period)
RO6889450 150 mg (Extension Period)
Risperidone 4 mg (Extension Period)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Add-On TherapyExperimental Treatment2 Interventions
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
Group II: Part A: MonotherapyExperimental Treatment2 Interventions
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO6889450
2016
Completed Phase 2
~460
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,294 Total Patients Enrolled
18 Trials studying Schizophrenia
7,904 Patients Enrolled for Schizophrenia
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,394 Total Patients Enrolled
17 Trials studying Schizophrenia
8,323 Patients Enrolled for Schizophrenia

Frequently Asked Questions

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

Has the FDA authorized RO6889450 for use?

"Our team gauged the safety of RO6889450 at a 2, signifying that there is some clinical evidence attesting to its security but none confirming effectiveness."

Answered by AI

What is the upper limit of participants involved in this research project?

"Affirmative. Information on clinicaltrials.gov asserts that this research initiative, which was initially posted in December 2018, is currently seeking volunteers to participate. A total of 247 people are needed from 27 various sites for the study's completion."

Answered by AI

Are there any opportunities to participate in this research endeavor at the moment?

"As per clinicaltrials.gov, this research is currently seeking participants; the initial posting was on December 4th 2018 and the study has recently been edited in November of 2022."

Answered by AI

How many centers is this investigation being conducted in?

"As of now, 27 medical centres across the United States are recruiting for this clinical trial. Some notable sites include Fort Worth, Costa Mesa and Glendale along with an additional 24 treatment locations. To reduce travel burden, it is best to pick a clinic that is most accessible to you should you choose to take part in the study."

Answered by AI

What criteria must an individual meet to qualify for participation in this research endeavor?

"This clinical trial seeks 247 volunteers with a diagnosis of schizophrenia to join their study. Applicants should be between 18 and 55 years old to qualify for participation."

Answered by AI

Is this experiment enlisting participants who are of age?

"This medical research requires that participants be within the 18 to 55 age bracket. For those younger than 18 or older than 65, there are 93 and 211 other clinical trials respectively available for them."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
California
How old are they?
18 - 65
What site did they apply to?
California Clinical Trials
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am open to trying a new experience, I like traveling, and the research on my condition interest me.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What will be tested at the screening what is it?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
2018. "A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03669640.
~20 spots leftby Apr 2025
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