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Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RBP-7000
Placebo
Risperidone
Sponsored by
Indivior Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizophrenic, Schizophrenias, Risperidone

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females between the ages of 18 to 55 years, inclusive
  • Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
  • Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and Rule (SAFER) interview
  • Subjects who are otherwise healthy on the basis of their physical examination

Exclusion Criteria:

  • Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment.
  • Subjects taking daily oral risperidone at a dose ≥ 6 mg/day
  • Subjects who have received a depot antipsychotic within 120 days of screen
  • Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.

Sites / Locations

  • Woodland International Research Group, Inc.
  • Woodland International Research Group, Inc.
  • Comprehensive Clinical Development - Cerritos, CA
  • Synergy Clinical Research of Escondido
  • Behavioral Research Specialists, LLC
  • Collaborative Neuroscience Networks, Inc.
  • Apostle Clinical Trials, Inc.
  • Pacific Research Partners
  • Excell Research, Inc.
  • CNRI- Los Angeles, LLC
  • CNRI - San Diego, LLC
  • Innovative Clinical Research
  • Behavioral Clinical Research, Inc.
  • Florida Clinical Research Center, LLC
  • Uptown Research Institute
  • Alexian Brothers Behavioral Health Hospital
  • Via Christi Research
  • Lake Charles Clinical Trials, LLC
  • J. Gary Booker, MD, APMC
  • St. Louis Clinical Trials
  • PsychCare Consultants Research
  • Altea Research Institute
  • CRI Lifetree
  • Neurobehavioral Research, Inc.
  • New Hope Clinical Research
  • Midwest Clinical Research Center, LLC
  • Oklahoma Clinical Research Center
  • CRI Lifetree
  • FutureSearch Clinical Trials, L.P.
  • Community Clinical Research, Inc.
  • FutureSearch Clinical Trials, L.P.
  • Pillar Clinic Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RBP-7000 90 mg

RBP-7000 120 mg

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 19, 2014
Last Updated
October 22, 2018
Sponsor
Indivior Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02109562
Brief Title
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indivior Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Schizophrenic, Schizophrenias, Risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBP-7000 90 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
RBP-7000 120 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RBP-7000
Other Intervention Name(s)
risperidone in Atrigel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Secondary Outcome Measure Information:
Title
Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)
Description
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.
Time Frame
Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Title
Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
Description
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.
Time Frame
Day 1 to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females between the ages of 18 to 55 years, inclusive Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and Rule (SAFER) interview Subjects who are otherwise healthy on the basis of their physical examination Exclusion Criteria: Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first day of treatment. Subjects taking daily oral risperidone at a dose ≥ 6 mg/day Subjects who have received a depot antipsychotic within 120 days of screen Subjects with treatment resistant schizophrenia, as judged by the investigator, who have been treated with antipsychotics for adequate durations and with adequate dosages.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Developoment Manager
Organizational Affiliation
Indivior Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland International Research Group, Inc.
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Comprehensive Clinical Development - Cerritos, CA
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Collaborative Neuroscience Networks, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Apostle Clinical Trials, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
CNRI- Los Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
CNRI - San Diego, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92012
Country
United States
Facility Name
Innovative Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Brothers Behavioral Health Hospital
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Lake Charles Clinical Trials, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
J. Gary Booker, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104-2136
Country
United States
Facility Name
St. Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CRI Lifetree
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Midwest Clinical Research Center, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Oklahoma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
CRI Lifetree
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
FutureSearch Clinical Trials, L.P.
City
Austin
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
FutureSearch Clinical Trials, L.P.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinic Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34551220
Citation
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.
Results Reference
derived
PubMed Identifier
34551219
Citation
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.
Results Reference
derived
PubMed Identifier
34551218
Citation
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.
Results Reference
derived

Learn more about this trial

Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

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