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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 Schizoaffective Disorder, sponsored by Braeburn Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
66
Enrollment target
1
Study location

NCT02658357: Completed Phase 2 study of Schizophrenia and Schizoaffective Disorder, sponsored by Braeburn Pharmaceuticals.

NCT02658357 is a Phase 2 study of Schizophrenia and Schizoaffective 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. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02658357, a Phase 2 study of Schizophrenia and Schizoaffective 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
Braeburn Pharmaceuticals

8 total trials

What the finished NCT02658357 record still lists

NCT02658357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (70% lower).

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 a single indexed study location in 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, Schizoaffective 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.

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02658357's enrollment target sits among peer trials

66 183rd of 315 higher than 133 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02658357, the US trial registry maintained by the National Library of Medicine. NCT02658357 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.