At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)
In Brief
A Phase 3 clinical trial evaluating Risperidone ISM 75 mg and Risperidone ISM 100 mg for Schizophrenia. Completed, enrolled 215 participants across 24 sites in 2 countries.
Detailed Summary
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.
Study Details
Timeline
Interventions
Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.