ROVI
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About
This is an open-label, one sequence study to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
Full description
This is an open-label, 1-sequence study in subjects who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
Subjects who are on existing oral risperidone treatment (4 mg) will continue the oral regimen for 1 week to achieve steady-state concentrations of risperidone. Following the oral risperidone treatment, a single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given that will be separated by 4 weeks.
Safety assessments and pharmacokinetic (PK) sampling will be performed on each dosing day and each outpatient visit. A final follow-up visit will take place to assess each subject for safety and to obtain PK samples.
Approximately 58 subjects will be enrolled, with the intent to complete 41 subjects. Fifty-eight subjects were estimated for enrollment based on 41 completers assuming an approximate drop-out rate of 30%.
The primary objective of this study is to evaluate the steady-state comparative bioavailability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
The secondary objective of this study is to evaluate the safety and tolerability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
Enrollment
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Inclusion and exclusion criteria
Subjects will be considered eligible to participate in this study if each one of the following inclusion criteria is satisfied at screening (or at baseline when specified):
Subjects will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at screening (or at baseline when specified):
Presence of an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that in the opinion of the investigator could have interfered with the interpretation of safety and PK evaluations
Presence of a clinically significant vital sign or physical examination finding that in the opinion of the investigator could potentially interfere with the ability to evaluate safety and tolerability of the trial medication or could impair the subject's ability to complete the trial
Presence of a clinically significant abnormality on blood or urine safety tests, which do not improve on retesting. In particular, laboratory and/or clinical evidence of clinically significant hepatic conditions, such as:
Corrected QT interval, Fridericia's correction (QTcF) interval greater than 450 msec for males and 470 msec for females, or other clinically significant ECG abnormality on screening or baseline
If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of trial medication, or is breastfeeding a child
Uncontrolled or unstable diabetes, or a clinically significant abnormal Hba1c blood level
Known or suspected (non-febrile) seizure disorder
Known serological evidence of human immunodeficiency (HIV) antibody
History of hepatitis B infection within the past year, or history of hepatitis C infection that has not been adequately treated and abnormal Liver Functional Tests (LFT) values
History of neuroleptic malignant syndrome
Current or past history of clinically significant tardive dyskinesia
Primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment
Known or suspected diagnosis of mental retardation or organic brain disorder
Positive urine drug/alcohol (ethanol breathalyzer is also acceptable) screen finding, unless the positive finding can be accounted for by documented prescription use. Individuals who have positive results for alcohol, cannabis, or other psychotropic substances but are not dependent on or abusing these substances may be included at the investigator's discretion, following a discussion between the investigator and the medical monitor
Heavy smoker (consumption of >40 cigarettes daily)
Fulfillment of the DSM-5 criteria for moderate or severe substance use disorder (excluding nicotine) within the past 6 months
Diagnosis of a psychotic disorder or a behavioral disturbance that is thought to be substance-induced or due to substance abuse
In the investigator's opinion, at imminent risk of committing self-harm or harm to others, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Individuals will be excluded if they report having suicidal ideation of Type 4 or 5 in the past 2 months, or suicidal behavior in the past 6 months, as measured by the C-SSRS at screening or baseline
On more than 1 antidepressant; or if on just one, a change in dose within the last 4 weeks prior to screen
Use of depot antipsychotics within the last 6 to 9 months
Use of electroconvulsive therapy (ECT) within the last 3 months
Use of moderate or strong cytochrome P450 3A4 (CYP3A4)enzyme inducers and inhibitors (carbamazepine, phenytoin, rifampicin, phenobarbital) or moderate or strong cytochrome P450 2D6 (CYP2D6) inhibitors (fluoxetine, paroxetine) (see Appendix 11.2) within 3 days or a time period of 5 half lives of the concerning drug, whichever is longer, prior to baseline
Unwilling to discontinue any of prohibited medications prior to the baseline visit; or, in the opinion of the investigator, is unable to safely taper off such medication without significant destabilization or increased risk of self-harm (suicide). Prohibited medications may include antipsychotics, phenobarbital, fluoxetine, fluoxetine combinations, paroxetine, benzodiazepines except lorazepam, diazepam, oxazepam, psychotropics, herbal drugs/dietary supplements for depression, anxiety, insomnia, rifampicin, and quinidine
Receipt of any investigational drugs within the last 3 months
Current participation in any other clinical trial
In the investigator's opinion, medically non-compliant in the management of his or her disease
Known or suspected allergy or hypersensitivity to risperidone or any of the ISM® excipients
Previous non-responder to risperidone treatment
Currently under involuntary in-patient commitment
Primary purpose
Allocation
Interventional model
Masking
81 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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