CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
PERSERIS +1 moredrug
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.

Search/NCT03978832
NCT03978832Phase 4Completed

An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of 180 mg Risperidone Subcutaneous Injection (PERSERIS) Following a Switch From 6 mg Oral Risperidone in Patients With Clinically Stable Schizophrenia

Indivior Inc.·interventional·Posted Jun 7, 2019·Updated Jul 7, 2021

In Brief

A Phase 4 clinical trial evaluating PERSERIS and Risperidone for Schizophrenia. Completed, enrolled 69 participants across 1 site.

Detailed Summary

This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 7, 2019
Enrollment StartJun 28, 2019
Primary CompletionMay 12, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.1 years ago

Interventions

PERSERISdrug

PERSERIS is an extended-release SC injectable suspension administered once-monthly

Risperidonedrug

Oral risperidone