Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute exacerbation of schizophrenia.

Timeline

Start

2017-06-02

Primary completion

2018-12-17

Completion

2018-12-17

Outcome

Met primary endpoint

paper The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM® 75 and 100 mg PMID 33239746 ↗

paper with placebo-adjusted differences of -13.0 (95% CI, -17.3 to -8.8); (p < 0.0001) PMID 33239746 ↗

paper and -13.3 (-17.6 to -8.9); (p < 0.0001), respectively. PMID 33239746 ↗

release “the final results of the pivotal PRISMA-3 clinical study confirm the superiority of Risperidone ISM®” rovi.es ↗

release “pivotal study of Risperidone ISM® “PRISMA-3” 1 , which showed that primary and key secondary efficacy endpoints were achieved” rovi.es ↗

release “pivotal study of Risperidone ISM® “PRISMA-3”1, which showed that primary and key secondary efficacy endpoints were achieved” rovi.es ↗

release “PRISMA-3” 1, which showed that primary and key secondary efficacy endpoints were achieved with both doses tested for the treatment of” rovi.es ↗

Publications

• Results Correll CU, Litman RE, Filts Y, Llaudo J, Naber D, Torres F, Martinez J. Efficacy and safety of once-monthly Risperidone ISM(R) in schizophrenic patients with an acute exacerbation. NPJ Schizophr. 2020 Nov 25;6(1):37. doi: 10.1038/s41537-020-00127-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	75 mg	Intramuscular
Subject	Risperidone	Other / unclassified	100 mg	Intramuscular

Indications