NCT04512066

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

A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	RO6889450	Participants will receive oral RO6889450 QD.
DRUG	Placebo	Participants will receive oral placebo QD.
DRUG	Risperidone	Participants will receive oral risperidone QD.

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2020-08-13
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

40 sites across 4 countries: United States, Japan, Russia, Ukraine

Regulatory

• FDA-regulated drug study