Phase 3
N=500
Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02203838 ↗Enrolled (actual)
500
Serious AEs
6.8%
Results posted
Sep 2018
Primary outcome: Primary: Participants With Treatment-Emergent Adverse Events (TEAE) — 306; 21; 22; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RBP-7000 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Treatment-Emergent Adverse Events (TEAE) |
306; 21; 22; 18; 232; 12 | — |
| PRIMARY Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs) |
52; 2; 4; 7; 29; 1 | — |
| PRIMARY Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline |
106; 3; 4; 5; 67; 3 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study |
-1.2; -4.8; -8.3; -2.4; -1.2; -8.2 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study |
-1.3; -7.8; -3.7; -3.7; 1.3; -4.0 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study |
-0.0; -0.3; -0.2; -0.1; -0.1; -0.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02203838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.