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A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

NCT04512066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2023-10-10

Study results available
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Summary

This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

Conditions

  • Schizophrenia, Schizoaffective Disorder

Interventions

DRUG

RO6889450

Participants will receive oral RO6889450 QD.

DRUG

Placebo

Participants will receive oral placebo QD.

DRUG

Risperidone

Participants will receive oral risperidone QD.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-06-21
Completion
2022-06-21
FDA Drug
Yes

Countries

  • United States
  • Japan
  • Russia
  • Ukraine

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512066 on ClinicalTrials.gov