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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Risperidone

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