This trial is active, not recruiting.

Condition schizophrenia
Treatment rbp-7000 - 120-mg dose
Phase phase 3
Sponsor Indivior Inc.
Start date June 2014
End date October 2016
Trial size 500 participants
Trial identifier NCT02203838, RB US 13-0005


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
RBP-7000 120-mg subcutaneous (SC) dose. A 14-day period of titration to a dose of 3- or 4mg oral risperidone before the first injection of RBP-7000
rbp-7000 - 120-mg dose Risperidone
120-mg of RBP-7000 dose Patients subject to a one-time down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion

Primary Outcomes

Number of patients who experience treatment emergent adverse events (TEAEs)
time frame: Day 1 up to week 58

Secondary Outcomes

Change from baseline in total Positive and Negative Syndrome Scale (PANSS)
time frame: Day 1 up to week 58
Change in total clinical global impression - severity of illness (CGI-S) scale
time frame: Day 1 up to week 58

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 plus/minus70 at the time of screening (Visit 1), which is confirmed at baseline (Visit 6) - Deemed 'valid' by a State, Assessability, Face, Ecological and Rule (SAFER) interview with an independent expert centralized rater - 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 sustained-release formulation within 120 days of study screening (Visit 1) - Patients who have received a sustained-release or depot 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 x the upper limit or normal (ULN), or - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2x ULN - Patients with a history of drug-induced leucopenia - 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

Additional Information

Official title An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia
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), 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 stud RB-US-09-0010 and are categorized as "run-in" patients. "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 the "run-in-phase"; that is over a 14-day period by titrating up to a dose of 3- or 4-mg oral risperidone/day before the first injection of RBP-7000, only if clinically indicated. "De novo" "conversion" patients are patients who are receiving oral risperidone doses other than 3 or 4mg/day and will begin the oral risperidone the oral risperidone "conversion" phase over a seven-day period to achieve an oral risperidone dose level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated. "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 phase with oral risperidone. On Visit 6 (Day 1±2 days) of the open-label study (Day 57 of Study RB-US-09-0010), patients will receive their first dose (120 mg) of open label RBP-7000.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Indivior Inc..