drugset / Trial / NCT03160521

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

NCT03160521

Phase 3 Completed 438 enrolled Rovi Pharmaceuticals Laboratories
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 75 mg Intramuscular
Subject Risperidone Other / unclassified 100 mg Intramuscular

Indications