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

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02203838

Run by

Indivior Inc.

People needed

500

Starts

2014-06-01

Expected to finish

2016-09-01

Last updated by the study team

2018-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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