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

NCT03160521 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ROV-RISP-2016-01
• Study Type: interventional
• Target: 438
• Locations: 2 countries
• Sites: 31

Brief 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.

Conditions

Acute Schizophrenia

Outcome Measures

Primary Outcomes (1)

• PANSS Total Score Mean Change From Baseline to Endpoint

  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 indicate improvements in symptoms whereas higher scores mean a worse outcome. Endpoint is defined as study day 85 or the last post-baseline assessment if early discontinuation.

  Day 1 (Baseline) and Day 85 (or the last post-baseline assessment)

Secondary Outcomes (7)

• CGI-S Total Score Mean Change From Baseline to Endpoint

  Day 1 (Baseline) and Day 85 (or the last post-baseline assessment)

• CGI-I Score Mean at Endpoint

  Day 1 (Baseline) and Day 85 (or the last post-baseline assessment)

• Overall Response Rate at Endpoint

  Day 85 or the last post-baseline assessment

• PANSS Response Rate at Endpoint

  Day 85 or the last post-baseline assessment

• PANSS Positive Subscale Mean Change From Baseline to Endpoint

  Day 1 (Baseline) and Day 85 (or the last post-baseline assessment)

Other Outcomes (3)

• PSP Total Score From Baseline at Each Post-baseline Assessment Time Point

  Day 1 (Baseline), Days 29, 57 and 85 (or the last post-baseline assessment)

• SWN-20 Total Score From Baseline at Each Post-baseline Assessment Time Point

  Day 1 (Baseline), Days 29, 57 and 85 or the last post-baseline assessment

• Plasma PK Parameters

  Day 3 and Day 29 after Dose 1, 2 and 3

Study Arms (3)

Risperidone ISM 75 mg

EXPERIMENTAL

Patients assigned to this arm will received 75 mg of Risperidone ISM during double-blind treatment period.

Drug: Risperidone ISM 75 mg

Risperidone ISM 100 mg

EXPERIMENTAL

Patients assigned to this arm will received 100 mg of Risperidone ISM during double-blind treatment period.

Drug: Risperidone ISM 100 mg

Placebo

PLACEBO COMPARATOR

Patients assigned to this arm will received placebo of Risperidone ISM during double-blind treatment period.

Drug: Placebo of Risperidone ISM

Interventions

Risperidone ISM 75 mg DRUG

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Also known as: Risperidone ISM

Risperidone ISM 75 mg

Risperidone ISM 100 mg DRUG

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Also known as: Risperidone ISM

Risperidone ISM 100 mg

Placebo of Risperidone ISM DRUG

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Also known as: PLACEBO

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for enrolment into the study, each patient must meet all of the following criteria at screening:
• Capable of providing informed consent
• A signed informed consent form must be provided before any study assessments are performed
• Patients must be fluent in the language that is spoken by the investigator and the study site staff (including raters) and must be able to read and understand the words in which the informed consent is written
• Age ≥ 18 and ≤ 65 years
• Body mass index 18.5 to 40.0 kg/m2 (inclusive)
• Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
• Currently experiencing an acute exacerbation or relapse with onset \< 2 months before screening
• If inpatient at screening, has been hospitalized for \< 2 weeks for the current exacerbation
• ≥ 2 years have elapsed since initial onset of active-phase schizophrenia symptoms
• Has been able to achieve outpatient status for \> 4 months during the past year
• Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine
• Agrees to discontinue prohibited medications as applicable and as clinically indicated according to investigator instructions
• Dosages of all permitted medications are considered to have been stable (with the exception of medication to be used on an as-needed basis) for ≥ 2 weeks prior to the baseline visit and to remain stable during participation in this study
• Positive and Negative Syndrome Scale (PANSS) results at the screening and baseline visits meets the following criteria:

You may not qualify if:

• An individual who meets any of the following criteria at screening will not be permitted to enroll in the study:
• History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone
• History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)
• Improvement in PANSS total score 20% or greater between the initial screening visit and first injection
• Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these
• History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or tardive dystonia
• History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments
• Clinically significant extrapyramidal symptoms at screening or baseline
• Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year
• Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing
• Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder
• Clinically significant comorbid neuropsychiatric disorders including any of the following:
• Current untreated or unstable major depressive disorder
• Clinically significant cognitive difficulties including dementia, delirium, or amnesic syndrome, within the past 2 years and would interfere with participation in the study
• Any other psychiatric condition that would, in the judgment of the investigator, interfere with participation in the study

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (31)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

CIMU Bellflower

Cerritos, California, 90703, United States

Location

Collaborative Neuroscience Network, LLC.

Garden Grove, California, 92845, United States

Location

Synergy Research San Diego

Lemon Grove, California, 91945, United States

Location

Apostle Clinical Trials

Long Beach, California, 90813, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

CNRI-Los Angeles LLC

Pico Rivera, California, 90660, United States

Location

CNRI-San Diego

San Diego, California, 92112, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Innovative Clinical Research Inc.

Hollywood, Florida, 33021, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

CBH Health LLC

Gaithersburg, Maryland, 20877, United States

Location

Precise Research Centers MS

Flowood, Mississippi, 39232, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Carolina Clinical Triasl Inc

Charleston, South Carolina, 29407, United States

Location

Community Clinical Research Inc.

Austin, Texas, 78754, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research LLC

Richardson, Texas, 75080, United States

Location

Regional Clinical Hospital n.a I.I. Mechnicov

Dnipro, 49005, Ukraine

Location

Kharkiv Regional Clinical Psychiatric Hospital

Kharkiv, 61068, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

Kherson Regional Psychiatric Hospital

Kherson, 73488, Ukraine

Location

Kiev City Psychiatric Hospital No. 2

Kiev, 02192, Ukraine

Location

Kyiv Regional Medical Association "Psykhiatriya" in Kyiv

Kiev, 04080, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital. Department 20

Lviv, 79021, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital. Department 25

Lviv, 79021, Ukraine

Location

Odesa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Maltsev Regional Clinical Psychiatric Ho

Poltava, 36013, Ukraine

Location

N.I. Pyrogov Vinnytsya Natl Medical University

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• Correll CU, Litman RE, Filts Y, Llaudo J, Naber D, Torres F, Martinez J. Efficacy and safety of once-monthly Risperidone ISM(R) in schizophrenic patients with an acute exacerbation. NPJ Schizophr. 2020 Nov 25;6(1):37. doi: 10.1038/s41537-020-00127-y.

  PMID: 33239746 RESULT

Results Point of Contact

• Title: Director of Medical Department
• Organization: Laboratorios Farmacéuticos Rovi, S.A.

departamento.medico@rovi.es

91 375 62 30

Study Officials

• Robert Litman

  CBH Health LLC

  PRINCIPAL INVESTIGATOR

• Yuriy Filts

  CI Lviv Regional Clinical Psychiatric Hospital. Department 25

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study drug will be administered under double-blind conditions so that investigators, site staff, and patients will not be aware about the identity of the study drug (ie, blinded Risperidone ISM 75 mg, Risperidone ISM 100 mg, or placebo) administered to any given patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 19, 2017
• Study Start: June 2, 2017
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: February 22, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); UA (11)