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This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness (CGI-S) scale.
Patients to be screened must be diagnosed with schizophrenia with a designated score based on the PANSS, as confirmed by a State, Assessability, Face, Ecological and Rule (SAFER) interview. "De novo" patients are patients who are already receiving 3- or 4-mg oral risperidone/day and will not have to complete the "run-in" or "conversion" phases (see below) and will be assigned to receive RBP-7000 after eligibility has been confirmed. Patients who completed the double-blind, placebo-controlled, efficacy study of RBP-7000 (RB-US-09-0010, NCT02109562), conducted in patients with acute schizophrenia (referred to as "roll-over" patients) will be screened.
All patients will be assigned the 120 mg dose of RBP-7000, which is subject to a one-time down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion. Patients receiving the 90-mg dose of RBP-7000 who exhibit a worsening in psychiatric symptoms, confirmed by a total PANSS score >70 or a 20% increase in the PANSS score from the previous assessment at the 120-mg dose level (before the dose was decreased to 90 mg), can receive a one-time, up-titration back to 120-mg RBP-7000 at the discretion of the investigator.
"De novo" patients entering into the study are those patients who did not participate in study RB-US-09-0010 (NCT02109562) and are allocated into three groups with different pre-study procedures to prepare for the treatment period:
"Roll-over" patients entering into the study are patients who completed 56 days of double-blind treatment in Study RB-US-09-0010. These patients will be eligible to enter the current study provided that continuation of treatment is clinically warranted, as judged by the investigator, and that there have been no significant protocol deviations or clinically relevant adverse events (AEs) that would preclude inclusion in this study. Roll-over patients will not undergo the complete screening process and will not require either a run-in or conversion period with oral risperidone. On Day 1 of the open-label study (which is Day 57 of Study RB-US-09-0010), patients will receive their first injection (120 mg) of open label RBP-7000.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBP-7000 - 120-mg dose | Experimental | RBP-7000 120-mg subcutaneous (SC) injections every 28 days for 13 doses as open-label therapy. Patients enter the study as 'roll-over' patients from study RB-US-09-0010, or de novo patients. Pre-study procedures vary for de novo patients depending on previous therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBP-7000 | Drug | 120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010). A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 up to week 52 |
| Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs) | 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. Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories. | Day 1 up to week 52 |
| Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline | Participants who were found to have gain >=7% and >=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began. | Baseline (Day 0), Treatment (Day 1 up to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study | 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. |
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Inclusion Criteria:
"De Novo" Patients
"Roll-over Patients
Exclusion Criteria:
"De Novo" Patients
Patients taking daily oral risperidone at a dose plus/minus 6 mg/day
Patients taking any risperidone or 9-hydroxyrisperidone long-acting injectable formulation within 120 days of study screening (Visit 1)
Patients who have received a long-acting injectable antipsychotic within 120 days of screening (Visit 1)
Patients with evidence or history (in the past six months prior to screening) of a significant hepatic disorder that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug, including:
Patients with a history of drug-induced leukopenia
Patients with other medical conditions including, but not limited to, history of heart attack (myocardial infarction) or brain injury (traumatic injury with loss of consciousness and/or cerebrovascular accident), and clinically significant low blood pressure or arrhythmias as interpreted by the primary investigator (PI) or medically qualified sub-investigator
Patients with epilepsy or other seizure disorders, Parkinson's disease or dementia
"Roll-over" Patients
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| Name | Affiliation | Role |
|---|---|---|
| Indivior Inc. | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | United States | ||
| Woodland Research Northwest, LLC |
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A total of 820 subjects were screened for study participation at 53 sites in the US.
Overall, 500 participants were included in the Safety Population: 92 rollover participants and 408 de novo participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | De Novo Participants | Participants who were not part of the previous double-blind study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg of RBP-7000 at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study | PANSS subscales:
| Baseline (Day 0), End of Study (approximately Week 52) |
| Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study | 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. | Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| Comprehensive Clinical Development | Cerritos | California | 90703 | United States |
| Synergy EPIC | Escondido | California | 92025 | United States |
| Behavioral Research Specialists | Glendale | California | 91206 | United States |
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | United States |
| Apostle Clinical Trials | Long Beach | California | 90813 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| CNRI-Los Angeles | Pico Rivera | California | 90660 | United States |
| CNRI-San Diego | San Diego | California | 92102 | United States |
| Research Center for Clinical Studies | Norwalk | Connecticut | 06851 | United States |
| Comprehensive Clinical Development-Washington DC | Washington D.C. | District of Columbia | 20016 | United States |
| Florida Clinical Research Center | Bradenton | Florida | 34201 | United States |
| Innovative Clinical Research | Fort Lauderdale | Florida | 33308 | United States |
| Behavioral Clinical Reserach | Hollywood | Florida | 33021 | United States |
| Florida Clinical Research Center | Maitland | Florida | 32751 | United States |
| Premier Clinical Resarch Institute | Miami | Florida | 33122 | United States |
| Radiant Research | Atlanta | Georgia | 30328 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Behavioral Health Hospital | Hoffman Estates | Illinois | 60169 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| Via Christi Research | Wichita | Kansas | 67214 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| Centerpointe Hospital | Saint Charles | Missouri | 63304 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63118 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| CRI Lifetree - Marlton Unit | Marlton | New Jersey | 08053-3426 | United States |
| Behavioral Medical Research of Brooklyn | Brooklyn | New York | 11241 | United States |
| Neurobehavioral Research | Cedarhurst | New York | 11516 | United States |
| Comprehensive Clinical Development-Queens | Jamaica | New York | 11432 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28204 | United States |
| Clinical Trials of America | Hickory | North Carolina | 28601 | United States |
| Insight Clinical Trials LLC | Shaker Heights | Ohio | 44122 | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Keystone Clinical Studies | Norristown | Pennsylvania | 19403 | United States |
| CRI Lifetree - Philadelphia Unit | Philadelphia | Pennsylvania | 19139 | United States |
| Berks Center for ClinicalResearch | Reading | Pennsylvania | 19604 | United States |
| Research Strategies of Memphis | Memphis | Tennessee | 38119 | United States |
| FutureSearch Clinical Trials | Austin | Texas | 78731 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| FutureSearch Clinical Trials, L.P. | Dallas | Texas | 75231 | United States |
| Pillar Clinical Research | Dallas | Texas | 75243 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| Alliance Research Group | Richmond | Virginia | 23230 | United States |
| FG001 | Rollover Placebo | Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| FG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| FG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | De Novo Participants | Participants who were not part of the previous double-blind study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| BG001 | Rollover Placebo | Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| BG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| BG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| BG004 | 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 |
| |||||||||||
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Ethnicity | Count of Participants | Participants |
| ||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Waist-to-Hip Ratio | A measurement of abdominal fat. | Measurement not taken for 10 De Novo participants. | Mean | Standard Deviation | ratio |
| ||||||||
| Child-bearing Potential | Females only | Count of Participants | Participants |
| ||||||||||
| Positive and Negative Syndrome Scale (PANSS) | 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. | Mean | Standard Deviation | units on a scale |
| |||||||||
| 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". | Mean | Standard Deviation | units on a scale |
|
| 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 | 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 -- participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to week 52 |
|
|
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| Primary | Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs) | 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. Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories. | Safety population | Posted | Count of Participants | Participants | Day 1 up to week 52 |
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| Primary | Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline | Participants who were found to have gain >=7% and >=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began. | Safety population of study participants with a baseline weight recorded and at least one post-treatment weight recorded. | Posted | Count of Participants | Participants | Baseline (Day 0), Treatment (Day 1 up to Week 52) |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study | 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. | Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study | PANSS subscales:
| Safety population. Population counts represent participants with an end of study observation (all participants had baseline assessments). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), End of Study (approximately Week 52) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study | 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. | Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52) |
|
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 | De Novo Participants | Participants who were not part of the previous double-blind study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. | 3 | 408 | 25 | 408 | 228 | 408 |
| EG001 | Rollover Placebo | Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. | 1 | 28 | 3 | 28 | 14 | 28 |
| EG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. | 0 | 31 | 3 | 31 | 17 | 31 |
| EG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. | 0 | 33 | 3 | 33 | 13 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diverticulitus | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonany embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA (17.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
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| >=1 TEAE related to study drug |
|
| >=1 serious TEAE |
|
| >=1 serious and related TEAE |
|
| TEAE leading to dose modification |
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| TEAE leading to discontinuation |
|
| TEAE leading to death |
|
| OG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
|
|
| OG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
|
|
Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
|
|
| OG001 | Rollover Placebo | Participants who were randomized to the placebo arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 13 subcutaneous injections of 120 mg RBP-7000 28 days apart. A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
|
|
| OG002 | Rollover RBP-7000 90 mg | Participants who were randomized to the RBP-7000 90 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
| OG003 | Rollover RBP-7000 120 mg | Participants who were randomized to the RBP-7000 120 mg arm in the double-blind study RB-US-09-0010 prior to entering this study. Treatment consisted of 11 subcutaneous injections of 120 mg RBP-7000 28 days apart (13 injections total counting the previous study). A one-time down-titration to 90 mg RBP-7000 was permitted at the investigator's discretion if the participant had tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. |
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