At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 500 enrolled

Drug / intervention

RBP-7000drug

Likely dose

RBP-7000 90 mgfrom 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/NCT02203838

NCT02203838Phase 3Completed

Compare CT.gov

An Open-Label, Long-Term Safety and Tolerability Study of RBP-7000 in the Treatment of Subjects With Schizophrenia

Indivior Inc.·interventional·Posted Jul 30, 2014·Updated Sep 28, 2018

In Brief

A Phase 3 clinical trial evaluating RBP-7000 for Schizophrenia. Completed, enrolled 500 participants across 48 sites.

Detailed Summary

This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness (CGI-S) scale.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSchizophrenia

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJun 2014

First PostedJul 2014

Primary CompletionSep 2016

TodayJul 2026

First PostedJul 30, 2014

Enrollment StartJun 1, 2014

Primary CompletionSep 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 11.9 years ago

Interventions

RBP-7000drug

120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010). A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator. RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner.