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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone ISM 75 mg | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone ISM 75 mg | Drug | Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | Baseline and Day 365 (or the last post-baseline assessment) |
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| Measure | Description | Time Frame |
|---|---|---|
| PANSS Positive Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. |
Participation in the open-label extension segment of the study PRISMA-3 is optional, and patients who complete participation in the main segment of the study (double blind segment of PRISMA-3, NCT03160521) may opt to not participate. Patients who are interested in participating must meet all eligibility criteria in order to enter into the extension segment.
Inclusion Criteria (Rollover patients):
To be eligible for entry into the extension segment of the study PRISMA-3, a patient must meet all of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the main part of the study):
Has completed scheduled participation in the double blind segment of the study PRISMA-3, through to the end of the treatment period and including the end-of-treatment visit
Continues to require long-term treatment with an antipsychotic medication, in the opinion of the investigator
Continues to meet contraceptive requirements of the study PRISMA-3
Is willing to participate in the extension segment of the study and remains capable of providing informed consent
a. A signed informed consent form must be provided before any study assessments are performed for the extension segment
Continues to reside in a stable living situation, in the opinion of the investigator
Continues to have an identified reliable informant, in the opinion of the investigator
Exclusion Criteria (Rollover patients):
An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:
Inclusion Criteria (De Novo Patients):
Capable of providing informed consent
Age ≥ 18 and ≤ 65 years old
On a stable dose of oral risperidone from 4 to 6 mg daily as maintenance therapy for at least the last 4 weeks prior/before screening/baseline and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria that is clinically stable as evidenced by:
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
At least 2 years elapsed since initial onset of active-phase schizophrenia symptoms
Subject is outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)
Medically stable over the last month prior to screening based on the investigator's judgment
BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening
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
Resides in a stable living situation, in the opinion of the investigator
Has an identified reliable informant, in the opinion of the investigator
Meets the contraceptive criteria stablished in the study
Agrees not to post any personal medical data related to the study or information related to the study on any website or social media site during the study duration.
Exclusion Criteria (De Novo Patients):
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| Name | Affiliation | Role |
|---|---|---|
| Robert Litman | CBH Health LLC | Principal Investigator |
| Yuriy Filts | CI Lviv Regional Clinical Psychiatric Hospital. Department 25 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States | ||
| Collaborative Neuroscience Network, LLC. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34847501 | Result | Filts Y, Litman RE, Martinez J, Anta L, Naber D, Correll CU. Long-term efficacy and safety of once-monthly Risperidone ISM(R) in the treatment of schizophrenia: Results from a 12-month open-label extension study. Schizophr Res. 2022 Jan;239:83-91. doi: 10.1016/j.schres.2021.11.030. Epub 2021 Nov 27. |
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Patients enter the study as rollover patients from the previous double-blind (DB) study (NCT03160521), along with newly enrolled de novo patients. Rollover patients received Risperidone ISM in the OLE study at the same dose as during the DB study (75 mg or 100 mg). Patients who received placebo in the DB were assigned to receive either Risperidone ISM 75 or 100 mg during the OLE. De novo patients received either Risperidone ISM 75 or 100 mg depending on the previous oral risperidone treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rollover Placebo/Risperidone ISM 75 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. |
| FG001 | Rollover Risperidone ISM 75mg/Risperidone ISM 75mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2018 | Jan 19, 2022 |
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It is an open label extension
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| Risperidone ISM 100 mg | Drug | Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle. |
|
| Baseline and Day 365 (or the last post-baseline assessment) |
| PANSS Negative Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | Baseline and Day 365 (or the last post-baseline assessment) |
| PANSS General Psychopathology Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The general psychopathology scale consists of 16 items which measure somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. PANSS General Psychopathology Subscale Score ranges from 16 (absence of symptoms) to 112 (extremely severe symptoms). Endpoint is defined as study day 356 or the last post-baseline assessment if early discontinuation. | Baseline and Day 365 (or the last post-baseline assessment) |
| Clinician Global Impression - Severity (CGI-S) Total Score Mean Change From Baseline to Endpoint | The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | Baseline and Day 365 (or the last post-baseline assessment) |
| Clinician Global Impression - Improvement (CGI-I) Score | The Clinical Global Impression - Improvement (CGI-I) is a single 7-point rating score total improvement, regardless of whether or not the change it is due entirely to drug treatment. Raters select one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; or 7, Very much worse. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | Day 365 (or the last post-baseline assessment) |
| Overall Response Rate at Endpoint | Overall response was defined as either PANSS total score ≥ 30% decrease from baseline, or CGI-I score of 2 (much improved) or 1 (very much improved). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | Day 365 (or the last post-baseline assessment) |
| Relapse Rate | Relapse was defined as either increase from baseline in PANSS total score ≥30% or rehospitalization for psychotic symptoms or use of adjunctive antipsychotic medication after stabilization. | Day 365 (or the last post-baseline assessment) |
| Patients With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. | Up to Day 365 (or the last post-baseline assessment) |
| TEAEs Leading to Study Drug Discontinuation | TEAEs which resulted in permanent study drug discontinuation | Up to Day 365 (or the last post-baseline assessment) |
| Patients With Treatment-related TEAEs | An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. The temporal relationship of the AE with the investigational medicinal product makes causality possible, and the AE cannot be due to another cause such as other drugs, a surgical intervention, or an underlying disease | Up to Day 365 (or the last post-baseline assessment) |
| Garden Grove |
| California |
| 92845 |
| United States |
| Apostle Clinical Trials Inc. | Long Beach | California | 90813 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| CNRI-Los Angeles LLC | Pico Rivera | California | 90660 | United States |
| CNRI-San Diego | San Diego | California | 92112 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Innovative Clinical Research Inc. | Hollywood | Florida | 33021 | United States |
| CBH Health LLC | Gaithersburg | Maryland | 20877 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Regional Clinical Hospital n.a I.I. Mechnicov | Dnipro | 49005 | Ukraine |
| Kharkiv Regional Clinical Psychiatric Hospital | Kharkiv | 61068 | Ukraine |
| Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry | Kharkiv | 61068 | Ukraine |
| Kherson Regional Psychiatric Hospital | Kherson | 73488 | Ukraine |
| Kiev City Psychiatric Hospital No. 2 | Kiev | 02192 | Ukraine |
| Kyiv Regional Medical Association "Psykhiatriya" in Kyiv | Kiev | 04080 | Ukraine |
| CI Lviv Regional Clinical Psychiatric Hospital. Department 20 | Lviv | 79021 | Ukraine |
| CI Lviv Regional Clinical Psychiatric Hospital. Department 25 | Lviv | 79021 | Ukraine |
| Odesa Regional Medical Centre of Mental Health | Odesa | 65006 | Ukraine |
| Maltsev Regional Clinical Psychiatric Ho | Poltava | 36013 | Ukraine |
| N.I. Pyrogov Vinnytsya Natl Medical University | Vinnytsia | 21005 | Ukraine |
Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. |
| FG002 | De Novo/Risperidone ISM 75mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| FG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| FG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| FG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
| COMPLETED |
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| NOT COMPLETED |
|
All analyses were undertaken on the population of patients who received at least one dose of study drug during the OLE study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rollover Placebo/Risperidone ISM 75 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. |
| BG001 | Rollover Risperidone ISM 75mg/Risperidone ISM 75mg | Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. |
| BG002 | De Novo/Risperidone ISM 75mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| BG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| BG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| BG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
| |||||||||||||||
| Years since Schizophrenia Diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Time since Acute Exacerbation or relapse (weeks) | This is a descriptive data to show there are no differences between the treatment groups and that they are balanced at baseline. The acute schizophrenia was defined by:
| Mean | Standard Deviation | Weeks |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | 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 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. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | PANSS Positive Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | PANSS Negative Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | PANSS General Psychopathology Subscale Mean Change From Baseline to Endpoint | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The general psychopathology scale consists of 16 items which measure somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. PANSS General Psychopathology Subscale Score ranges from 16 (absence of symptoms) to 112 (extremely severe symptoms). Endpoint is defined as study day 356 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Clinician Global Impression - Severity (CGI-S) Total Score Mean Change From Baseline to Endpoint | The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Clinician Global Impression - Improvement (CGI-I) Score | The Clinical Global Impression - Improvement (CGI-I) is a single 7-point rating score total improvement, regardless of whether or not the change it is due entirely to drug treatment. Raters select one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; or 7, Very much worse. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Mean | Standard Deviation | score on a scale | Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Overall Response Rate at Endpoint | Overall response was defined as either PANSS total score ≥ 30% decrease from baseline, or CGI-I score of 2 (much improved) or 1 (very much improved). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Relapse Rate | Relapse was defined as either increase from baseline in PANSS total score ≥30% or rehospitalization for psychotic symptoms or use of adjunctive antipsychotic medication after stabilization. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Patients With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. | Posted | Count of Participants | Participants | Up to Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | TEAEs Leading to Study Drug Discontinuation | TEAEs which resulted in permanent study drug discontinuation | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. | Posted | Count of Participants | Participants | Up to Day 365 (or the last post-baseline assessment) |
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| Other Pre-specified | Patients With Treatment-related TEAEs | An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. The temporal relationship of the AE with the investigational medicinal product makes causality possible, and the AE cannot be due to another cause such as other drugs, a surgical intervention, or an underlying disease | The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. | Posted | Count of Participants | Participants | Up to Day 365 (or the last post-baseline assessment) |
|
Day 1 to week 52
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risperidone ISM 75 mg | Patients assigned to this arm will received 75 mg of Risperidone ISM during the open label extension. Risperidone ISM 75 mg: Monthly intramuscular (IM) injection in the gluteal or deltoid muscle. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. | 1 | 116 | 6 | 116 | 81 | 116 |
| EG001 | Risperidone ISM 100 mg | Patients assigned to this arm will received 100 mg of Risperidone ISM during the open label extension. Risperidone ISM 100 mg: Monthly IM injection in the gluteal or deltoid muscle. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. | 0 | 99 | 5 | 99 | 59 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
The sponsor does not object to publication by the Institution of the results of the Trial based on information collected/generated by the Institution. The Institution will provide Sponsor an opportunity to review any proposed publication before it is submitted. If the Trial is part of a multi-center trial, the Institution agress that the first publication is to be a joint publication involving all Trials sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Department | Laboratorios Farmacéuticos Rovi, S.A. | 91 375 62 30 | departamento.medico@rovi.es |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2019 | Jan 19, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2018 | Jan 19, 2022 | ICF_002.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Ukraine |
|
| OG002 | De Novo/Risperidone ISM 75 mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| OG002 | De Novo/Risperidone ISM 75 mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Risperidone ISM 100/Risperidone ISM 100 | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study.
| OG002 | De Novo/Risperidone ISM 75mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| OG002 |
| De Novo/Risperidone ISM 75mg |
Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| OG002 | De Novo/Risperidone ISM 75mg | Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. |
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| OG003 | Rollover Placebo/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG004 | Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg | Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. |
| OG005 | De Novo/Risperidone ISM 100 mg | Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|