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

NCT ID: NCT02203838

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-09-30

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.

Detailed Description

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:

• "Run-in" patients are patients who are not already receiving oral risperidone (as no other antipsychotic medications are allowed during study participation) and will begin a 14-day run-in period by titrating up to a dose of 3 or 4 mg oral risperidone/day before the first injection of RBP-7000.
• "Conversion" patients are patients who are receiving oral risperidone doses other than 3 or 4mg/day and will begin a 7-day conversion period to achieve an oral risperidone dose level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated.
• De novo patients taking an oral risperidone dose of 3 or 4 mg/day prestudy will (once screened/enrolled) receive the first injection of RBP-7000.

"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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RBP-7000 - 120-mg dose

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.

Group Type: EXPERIMENTAL

RBP-7000

Intervention Type: 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.

Interventions

RBP-7000

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.

Intervention Type: DRUG

Other Intervention Names

Risperidone; Long-acting Risperidone

Eligibility Criteria

Inclusion Criteria

"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

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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indivior Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Indivior Inc.

Role: STUDY_DIRECTOR

Indivior Inc.

Locations

Woodland International Research Group, Inc.

Little Rock, Arkansas, United States

Woodland Research Northwest, LLC

Springdale, Arkansas, United States

Comprehensive Clinical Development

Cerritos, California, United States

Synergy EPIC

Escondido, California, United States

Behavioral Research Specialists

Glendale, California, United States

Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Apostle Clinical Trials

Long Beach, California, United States

Pacific Research Partners

Oakland, California, United States

Excell Research

Oceanside, California, United States

CNRI-Los Angeles

Pico Rivera, California, United States

CNRI-San Diego

San Diego, California, United States

Research Center for Clinical Studies

Norwalk, Connecticut, United States

Comprehensive Clinical Development-Washington DC

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

Florida Clinical Research Center

Bradenton, Florida, United States

Innovative Clinical Research

Fort Lauderdale, Florida, United States

Behavioral Clinical Reserach

Hollywood, Florida, United States

Florida Clinical Research Center

Maitland, Florida, United States

Premier Clinical Resarch Institute

Miami, Florida, United States

Radiant Research

Atlanta, Georgia, United States

iResearch Atlanta

Decatur, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Behavioral Health Hospital

Hoffman Estates, Illinois, United States

Baber Research Group

Naperville, Illinois, United States

Via Christi Research

Wichita, Kansas, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Centerpointe Hospital

Saint Charles, Missouri, United States

St. Louis Clinical Trials

St Louis, Missouri, United States

Altea Research Institute

Las Vegas, Nevada, United States

CRI Lifetree - Marlton Unit

Marlton, New Jersey, United States

Behavioral Medical Research of Brooklyn

Brooklyn, New York, United States

Neurobehavioral Research

Cedarhurst, New York, United States

Comprehensive Clinical Development-Queens

Jamaica, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Clinical Trials of America

Hickory, North Carolina, United States

Insight Clinical Trials LLC

Shaker Heights, Ohio, United States

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Keystone Clinical Studies

Norristown, Pennsylvania, United States

CRI Lifetree - Philadelphia Unit

Philadelphia, Pennsylvania, United States

Berks Center for ClinicalResearch

Reading, Pennsylvania, United States

Research Strategies of Memphis

Memphis, Tennessee, United States

FutureSearch Clinical Trials

Austin, Texas, United States

Community Clinical Research, Inc.

Austin, Texas, United States

FutureSearch Clinical Trials, L.P.

Dallas, Texas, United States

Pillar Clinical Research

Dallas, Texas, United States

Bayou City Research

Houston, Texas, United States

Alliance Research Group

Richmond, Virginia, United States

Countries

United States

Other Identifiers

RB-US-13-0005

Identifier Type: -

Identifier Source: org_study_id