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 ↗

Phase 2 Completed 287 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-09-08
Primary completion: 2022-06-21
Completion: 2022-06-21

Publications

Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ralmitaront	Small molecule	45 mg	Oral
Subject	Ralmitaront	Small molecule	150 mg	Oral
Comparator	Risperidone	Other / unclassified	4 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications