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NCT02658357 · ClinicalTrials.gov registry record · Phase 2
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
A Phase 2 study of Schizophrenia and Schizo Affective Disorder, sponsored by Braeburn Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT02658357 is a Phase 2 study of Schizophrenia and Schizo Affective Disorder that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 66 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02658357, a Phase 2 study of Schizophrenia and Schizo Affective Disorder, has completed, sponsored by Braeburn Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Risperidone Implant
Study Locations (1)
Florida
- Segal Institute for Clinical Research 1201 North 37th Avenue - Hollywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02658357
The ClinicalTrials.gov registry entry for NCT02658357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (70% lower). The listed sponsor is Braeburn Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Risperidone Implant is the first listed.
NCT02658357 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02658357 about?
NCT02658357 is a clinical study titled "Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant". 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 Ri...
What is the current status of trial NCT02658357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2015-10. Estimated completion is 2017-08.
What conditions does trial NCT02658357 study?
This clinical trial studies the following conditions: Schizophrenia, Schizo Affective Disorder.
What interventions are being tested in trial NCT02658357?
The interventions under investigation include: Risperidone Implant (DRUG).
Who is sponsoring clinical trial NCT02658357?
This trial is sponsored by Braeburn Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02658357 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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