NCT03870880

Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who have completed planned participation in the double-blind segment of the study PRISMA-3 (NCT03160521) through to the end of the treatment period, may be eligible to enter into this optional long-term extension segment of the study. During this extension, open-label Risperidone ISM® (i.e., either 75 or 100 mg) will be administered to all participating patients once every 4 weeks for approximately 12 months. Patients who enter into the extension segment of the study will begin participation in the extension segment immediately upon completion of the end-of-treatment visit assessments and procedures. In addition to patients continuing from the double-blind segment of the study PRISMA-3 (rollover patients), clinically stable patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months. Approximately 100 de novo patients are planned to be enrolled in the extension segment of the study, in addition to rollover patients.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone ISM 75 mg	Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.
DRUG	Risperidone ISM 100 mg	Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Timeline

• Start date: 2017-08-25
• Primary completion: 2020-01-08
• Completion: 2020-01-08
• First posted: 2019-03-12
• Last updated: 2022-03-25
• Results posted: 2022-02-23

Locations

24 sites across 2 countries: United States, Ukraine

Regulatory

• FDA-regulated drug study