Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 5:35 PM
Study NCT ID:
NCT02658357
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2016-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
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
Sponsor:
Braeburn Pharmaceuticals
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: