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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.

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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.

Interventions

  • DRUG Risperidone Implant

Study Locations (1)

Florida

  • Segal Institute for Clinical Research 1201 North 37th Avenue - Hollywood

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2015-10
Est. Completion 2017-08
Phase Phase 2

Sponsor

Braeburn Pharmaceuticals

8 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.