Status:
COMPLETED
Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
Lead Sponsor:
Indivior Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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) inject...
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" ...
Eligibility Criteria
Inclusion
- "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
- "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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02203838
Start Date
June 1 2014
End Date
September 1 2016
Last Update
September 28 2018
Active Locations (48)
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1
Woodland International Research Group, Inc.
Little Rock, Arkansas, United States, 72211
2
Woodland Research Northwest, LLC
Springdale, Arkansas, United States, 72764
3
Comprehensive Clinical Development
Cerritos, California, United States, 90703
4
Synergy EPIC
Escondido, California, United States, 92025