Back to resultsStudy in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Primary Purpose
Schizophrenia, Schizo-affective Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Risperidone Implant
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subject (and/or a subject's authorized legal representative) has provided written informed consent
Patient meets the following criteria:
- Outpatient status
- PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
A score of ≤ 3 on the following PANSS items:
- Conceptual disorganization
- Suspiciousness
- Hallucinatory behavior
- Unusual thought content
- Subject is male or female between 18 to 60 years of age
- Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria
Exclusion Criteria:
- Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
- Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
- Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
- Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)
- Previously defined hypersensitivity to Risperidone
- History of neuromalignant syndrome (NMS)
- Electroconvulsive therapy within 6 months of admission
- Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Sites / Locations
- Segal Institute for Clinical Research 1201 North 37th Avenue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
600 mg
900 mg
Arm Description
Two, 300 mg Risperidone Implants
Three, 300 mg Risperidone Implants
Outcomes
Primary Outcome Measures
Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone
Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone
Secondary Outcome Measures
Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)
Full Information
NCT ID
NCT02658357
First Posted
January 7, 2016
Last Updated
February 6, 2020
Sponsor
Braeburn Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02658357
Brief Title
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Official Title
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braeburn Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.
Detailed Description
The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.
Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be recruited into the study.
Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300 mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm. Plasma concentrations of Risperidone and the active moiety will be measured prior to placement of the Risperidone Implants, throughout the implantation period, and after re-converting to oral Risperidone following the removal of the Risperidone Implants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo-affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
600 mg
Arm Type
Experimental
Arm Description
Two, 300 mg Risperidone Implants
Arm Title
900 mg
Arm Type
Experimental
Arm Description
Three, 300 mg Risperidone Implants
Intervention Type
Drug
Intervention Name(s)
Risperidone Implant
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time Frame
6 months
Title
Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject (and/or a subject's authorized legal representative) has provided written informed consent
Patient meets the following criteria:
Outpatient status
PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
A score of ≤ 3 on the following PANSS items:
Conceptual disorganization
Suspiciousness
Hallucinatory behavior
Unusual thought content
Subject is male or female between 18 to 60 years of age
Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria
Exclusion Criteria:
Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)
Previously defined hypersensitivity to Risperidone
History of neuromalignant syndrome (NMS)
Electroconvulsive therapy within 6 months of admission
Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Facility Information:
Facility Name
Segal Institute for Clinical Research 1201 North 37th Avenue
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
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