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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone ISM 75 mg; Drug: Risperidone ISM 100 mg

• Registration Number: NCT03870880
• Lead Sponsor: Rovi Pharmaceuticals Laboratories

Brief 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.

Study Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2019-02-26
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Primary Completion: 2020-01-08
• Study Completion: 2020-01-08
• Disposition First Submitted: 2020-11-26
• Disposition First Submitted QC: 2020-11-26
• Disposition First Posted: 2020-11-30
• Results First Submitted: 2022-01-28
• Results First Submitted QC: 2022-01-28
• Results First Posted: 2022-02-23
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperidone ISM 75 mg	Risperidone ISM 75 mg	Patients assigned to this arm will receive 75 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.
Risperidone ISM 100 mg	Risperidone ISM 100 mg	Patients assigned to this arm will receive 100 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.

Primary Outcome Measures

Name	Time	Method
PANSS Total Score Mean Change From Baseline to Endpoint	Baseline and Day 365 (or the last post-baseline assessment)	The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome.; Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

Trial Locations

Locations (24)

Apostle Clinical Trials Inc.; 🇺🇸 Long Beach, California, United States

Kharkiv Regional Clinical Psychiatric Hospital; 🇺🇦 Kharkiv, Ukraine

N.I. Pyrogov Vinnytsya Natl Medical University; 🇺🇦 Vinnytsia, Ukraine

Woodland Research Northwest; 🇺🇸 Rogers, Arkansas, United States

Collaborative Neuroscience Network, LLC.; 🇺🇸 Garden Grove, California, United States

CNRI-San Diego; 🇺🇸 San Diego, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Galiz Research; 🇺🇸 Hialeah, Florida, United States

CBH Health LLC; 🇺🇸 Gaithersburg, Maryland, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

Regional Clinical Hospital n.a I.I. Mechnicov; 🇺🇦 Dnipro, Ukraine

Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry; 🇺🇦 Kharkiv, Ukraine

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

Kiev City Psychiatric Hospital No. 2; 🇺🇦 Kiev, Ukraine

Kyiv Regional Medical Association "Psykhiatriya" in Kyiv; 🇺🇦 Kiev, Ukraine

CI Lviv Regional Clinical Psychiatric Hospital. Department 20; 🇺🇦 Lviv, Ukraine

Kherson Regional Psychiatric Hospital; 🇺🇦 Kherson, Ukraine

Maltsev Regional Clinical Psychiatric Ho; 🇺🇦 Poltava, Ukraine

CI Lviv Regional Clinical Psychiatric Hospital. Department 25; 🇺🇦 Lviv, Ukraine

Odesa Regional Medical Centre of Mental Health; 🇺🇦 Odesa, Ukraine

CNRI-Los Angeles LLC; 🇺🇸 Pico Rivera, California, United States

Innovative Clinical Research Inc.; 🇺🇸 Hollywood, Florida, United States

Altea Research Institute; 🇺🇸 Las Vegas, Nevada, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States