Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia

NCT02203838 | Completed Phase 3 Results

• 1 other identifier: RB-US-13-0005
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 48

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Schizophrenic; Schizophrenias; Risperidone; Long-acting Risperidone; Atrigel; Subcutaneous

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study

  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

  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

  Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)

Study Arms (1)

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.

Drug: RBP-7000

Interventions

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.

Also known as: Risperidone, Long-acting Risperidone

RBP-7000 - 120-mg dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "De Novo" Patients
• Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4, text revision (DSM-IV-TR) criteria
• Total PANSS score \<=70 at the time of screening (Visit 1)
• Otherwise healthy on the basis of physical examinatIon
• Provided written informed consent
• "Roll-over Patients
• Provided written consent to participate in this study
• Be considered eligible to enroll based on End of Study (EOS) (Day 57 of Study RB-US-09-0010) assessments and the medical judgment of the investigator

You may not qualify if:

• "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:
• Acute or chronic hepatitis, including but not limited to hepatitis B or C
• Total bilirubin greater than 1.5 times the upper limit of normal (ULN), or
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times ULN
• 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
• Patients requiring an inpatient treatment setting at the end of Study RB-US-09-0010
• Patients with an unstable medical condition developed during Study RB-US-09-0010
• Women of childbearing potential who have a positive pregnancy test at screening (Visit 1), who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (48)

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC

Springdale, Arkansas, 72764, United States

Location

Comprehensive Clinical Development

Cerritos, California, 90703, United States

Location

Synergy EPIC

Escondido, California, 92025, United States

Location

Behavioral Research Specialists

Glendale, California, 91206, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Apostle Clinical Trials

Long Beach, California, 90813, United States

Location

Pacific Research Partners

Oakland, California, 94612, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

CNRI-Los Angeles

Pico Rivera, California, 90660, United States

Location

CNRI-San Diego

San Diego, California, 92102, United States

Location

Research Center for Clinical Studies

Norwalk, Connecticut, 06851, United States

Location

Comprehensive Clinical Development-Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Florida Clinical Research Center

Bradenton, Florida, 34201, United States

Location

Innovative Clinical Research

Fort Lauderdale, Florida, 33308, United States

Location

Behavioral Clinical Reserach

Hollywood, Florida, 33021, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

Premier Clinical Resarch Institute

Miami, Florida, 33122, United States

Location

Radiant Research

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Via Christi Research

Wichita, Kansas, 67214, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Centerpointe Hospital

Saint Charles, Missouri, 63304, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63118, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

CRI Lifetree - Marlton Unit

Marlton, New Jersey, 08053-3426, United States

Location

Behavioral Medical Research of Brooklyn

Brooklyn, New York, 11241, United States

Location

Neurobehavioral Research

Cedarhurst, New York, 11516, United States

Location

Comprehensive Clinical Development-Queens

Jamaica, New York, 11432, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28204, United States

Location

Clinical Trials of America

Hickory, North Carolina, 28601, United States

Location

Insight Clinical Trials LLC

Shaker Heights, Ohio, 44122, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Keystone Clinical Studies

Norristown, Pennsylvania, 19403, United States

Location

CRI Lifetree - Philadelphia Unit

Philadelphia, Pennsylvania, 19139, United States

Location

Berks Center for ClinicalResearch

Reading, Pennsylvania, 19604, United States

Location

Research Strategies of Memphis

Memphis, Tennessee, 38119, United States

Location

FutureSearch Clinical Trials

Austin, Texas, 78731, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

FutureSearch Clinical Trials, L.P.

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research

Dallas, Texas, 75243, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Alliance Research Group

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Director, Clinical Development
• Organization: Indivior, Inc.

804-379-1090

Study Officials

• Indivior Inc.

  Indivior Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 28, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (48)