At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
Risperidone Implantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
In Brief
A Phase 2 clinical trial evaluating Risperidone Implant for Schizophrenia and Schizo-affective Disorder. Completed, enrolled 66 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizo-affective Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedJan 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedJan 18, 2016
Enrollment StartOct 1, 2015
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.5 years ago
Interventions
Risperidone Implantdrug