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The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.
This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBP-7000 90 mg | Experimental | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections. |
|
| RBP-7000 120 mg | Experimental | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections. |
|
| Placebo | Placebo Comparator | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBP-7000 | Drug | RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. 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. Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix. | Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S) | The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. 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. Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Developoment Manager | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | United States | ||
| Woodland International Research Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551220 | Derived | Andrade C. Prazosin for Alcohol Use Disorder: Reply to Sinha. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076a. doi: 10.4088/JCP.21lr14076a. No abstract available. | |
| 34551219 | Derived | Sinha R. Prazosin for Alcohol Use Disorder: A Clarification. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076. doi: 10.4088/JCP.21lr14076. No abstract available. |
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A total of 538 subjects were screened for study participation at 33 sites in the US, including 354 subjects randomly assigned to treatment. Four subjects were found to be randomized incorrectly; therefore, they were withdrawn from the study and did not receive study drug (counted as 'Physician Decision' for reason d/c below).
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| ID | Title | Description |
|---|---|---|
| FG000 | RBP-7000 90 mg | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections. |
| FG001 | RBP-7000 120 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29. |
|
| Risperidone | Drug | Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000). |
|
|
| Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation |
| Summary of Participants With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories. | Day 1 to Week 8 |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| Comprehensive Clinical Development - Cerritos, CA | Cerritos | California | 90703 | United States |
| Synergy Clinical Research of Escondido | Escondido | California | 92025 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Collaborative Neuroscience Networks, Inc. | Long Beach | California | 90806 | United States |
| Apostle Clinical Trials, Inc. | Long Beach | California | 90813 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| Excell Research, Inc. | Oceanside | California | 92056 | United States |
| CNRI- Los Angeles, LLC | Pico Rivera | California | 90660 | United States |
| CNRI - San Diego, LLC | San Diego | California | 92012 | United States |
| Innovative Clinical Research | Fort Lauderdale | Florida | 33308 | United States |
| Behavioral Clinical Research, Inc. | North Miami | Florida | 33021 | United States |
| Florida Clinical Research Center, LLC | Orlando | Florida | 32751 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Behavioral Health Hospital | Hoffman Estates | Illinois | 60169 | United States |
| Via Christi Research | Wichita | Kansas | 67214 | United States |
| Lake Charles Clinical Trials, LLC | Lake Charles | Louisiana | 70629 | United States |
| J. Gary Booker, MD, APMC | Shreveport | Louisiana | 71104-2136 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63118 | United States |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| CRI Lifetree | Marlton | New Jersey | 08053 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28204 | United States |
| Midwest Clinical Research Center, LLC | Dayton | Ohio | 45417 | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| CRI Lifetree | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials, L.P. | Austin | Texas | 78734 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| FutureSearch Clinical Trials, L.P. | Dallas | Texas | 75231 | United States |
| Pillar Clinic Research, LLC | Dallas | Texas | 75243 | United States |
| 34551218 | Derived | Le Moigne A, Csernansky J, Leadbetter RA, Andorn AC, Graham JA, Heath AT, Walling DP, Newcomer JW, Marder SR. PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients. J Clin Psychiatry. 2021 Sep 21;82(5):21m13906. doi: 10.4088/JCP.21m13906. |
Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
| FG002 | Placebo | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. |
| Safety | Randomized and received at least one dose of study drug |
|
| Intent to Treat (ITT) | Randomized, dosed, had a baseline and 1 or more post baseline efficacy measurements. |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | RBP-7000 90 mg | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections. |
| BG001 | RBP-7000 120 mg | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections. |
| BG002 | Placebo | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Waist-to-Hip Ratio | A measurement of abdominal fat. | Mean | Standard Deviation | ratio |
| ||||||||||||||
| Previous Antipsychotic Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Age at First Schizophrenia Diagnosis | Mean | Standard Deviation | years |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. 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. Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix. | Intent to treat (ITT) population | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation |
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| Secondary | Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S) | The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. 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. Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix. | Intent to treat population (ITT) | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation |
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| Secondary | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories. | Safety population | Posted | Count of Participants | Participants | Day 1 to Week 8 |
|
Day 1 to Week 8
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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 | RBP-7000 90 mg | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections. | 0 | 115 | 0 | 115 | 65 | 115 |
| EG001 | RBP-7000 120 mg | Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections. | 0 | 117 | 1 | 117 | 70 | 117 |
| EG002 | Placebo | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. | 0 | 118 | 1 | 118 | 64 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
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| Nodule | General disorders | MedDRA (17.0) | Systematic Assessment |
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Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multicenter publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Director, Clinical Development | Indivior, Inc. | 804-379-1090 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| 21 to 30 years |
|
| 31 to 40 years |
|
| 41 to 50 years |
|
| 51 to 55 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| No |
|
| Superiority |
| Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix. | repeated measure linear regression model | <0.0001 | For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure. | Mean Difference (Final Values) | -7.237 | Standard Error of the Mean | 1.7141 | 2-Sided | 95 | -11.045 | -3.429 | RBP-7000 120 mg - Placebo | Superiority |
| OG002 | Placebo | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. |
|
|
|
| OG002 | Placebo | Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections. |
|
|