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

NCT03870880 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2022-03-25

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rovi Pharmaceuticals Laboratories

    lead INDUSTRY

Principal Investigators

  • Robert Litman · CBH Health LLC

  • Yuriy Filts · CI Lviv Regional Clinical Psychiatric Hospital. Department 25

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2020-01-08
Completion
2020-01-08
FDA Drug
Yes

Countries

  • United States
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870880 on ClinicalTrials.gov