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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109562
• Other study ID #: RB-US-09-0010
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2018
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• RBP-7000
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.
• Placebo
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
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).

Locations

Country	Name	City	State
United States	Community Clinical Research, Inc.	Austin	Texas
United States	FutureSearch Clinical Trials, L.P.	Austin	Texas
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Comprehensive Clinical Development - Cerritos, CA	Cerritos	California
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Uptown Research Institute	Chicago	Illinois
United States	FutureSearch Clinical Trials, L.P.	Dallas	Texas
United States	Pillar Clinic Research, LLC	Dallas	Texas
United States	Midwest Clinical Research Center, LLC	Dayton	Ohio
United States	Synergy Clinical Research of Escondido	Escondido	California
United States	Innovative Clinical Research	Fort Lauderdale	Florida
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Alexian Brothers Behavioral Health Hospital	Hoffman Estates	Illinois
United States	Lake Charles Clinical Trials, LLC	Lake Charles	Louisiana
United States	Altea Research Institute	Las Vegas	Nevada
United States	Woodland International Research Group, Inc.	Little Rock	Arkansas
United States	Apostle Clinical Trials, Inc.	Long Beach	California
United States	Collaborative Neuroscience Networks, Inc.	Long Beach	California
United States	CRI Lifetree	Marlton	New Jersey
United States	Behavioral Clinical Research, Inc.	North Miami	Florida
United States	Pacific Research Partners	Oakland	California
United States	Excell Research, Inc.	Oceanside	California
United States	Oklahoma Clinical Research Center	Oklahoma City	Oklahoma
United States	Florida Clinical Research Center, LLC	Orlando	Florida
United States	CRI Lifetree	Philadelphia	Pennsylvania
United States	CNRI- Los Angeles, LLC	Pico Rivera	California
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	St. Louis Clinical Trials	Saint Louis	Missouri
United States	CNRI - San Diego, LLC	San Diego	California
United States	J. Gary Booker, MD, APMC	Shreveport	Louisiana
United States	Woodland International Research Group, Inc.	Springdale	Arkansas
United States	Via Christi Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
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.	Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
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.	Day 1 to Week 8