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NCT01696929 · ClinicalTrials.gov registry record · Phase 1

An Open-Label Trial of Tocilizumab in Schizophrenia

A Phase 1 study of Schizophrenia, sponsored by Brian Miller.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT01696929 is a Phase 1 study of Schizophrenia that has completed, run by Brian Miller. The registered enrollment target is 8 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01696929, a Phase 1 study of Schizophrenia, has completed, sponsored by Brian Miller.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass. Tocilizumab is formulated as a concentrate for solution for infusion, and will be administered by intravenous infusion. The investigators propose an 8-week trial to determine the safety, tolerability, and effectiveness of tocilizumab, given in addition to antipsychotic medications, in 10 stable outpatients with schizophrenia. The investigators hypothesize that tocilizumab will be associated with clinically significant improvement in cognition and total psychotic symptoms over the course of the trial. Tocilizumab is administered as an intravenous infusion every 4 weeks. Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. The investigators will measure changes in cognitive function and symptoms over an 8-week period. Complementing previous positive clinical trials of non-steroidal anti-inflammatory drugs, this would be a "proof-of-concept" study that targeting specific cytokines is a viable treatment for schizophrenia. Interleukin 6 and its receptor were discovered and cloned at Osaka University, Japan, by Tadamitsu Kishimoto in the 1980s. In 1997, Chugai Pharmaceuticals began the clinical development of tocilizumab for the treatment of rheumatoid arthritis. Clinical studies for Castleman's disease and systemic juvenile idiopathic arthritis started in 2001 and 2002, respectively. Hoffmann-La Roche co-developed the drug due to a license agreement in 2003. Data presented in 2008 showed the effectiveness of tocilizumab in combination therapy with methotrexate for rheumatoid arthritis treatment. I

Conditions Studied

Schizophrenia

Interventions

  • DRUG Tocilizumab

Study Locations (1)

Georgia

  • Georgia Health Sciences University - Augusta

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2012-09
Est. Completion 2014-12
Phase Phase 1

Sponsor

Brian Miller

1 total trials

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What the Registry Record Tells You About NCT01696929

The ClinicalTrials.gov registry entry for NCT01696929 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 (96% lower). The listed sponsor is Brian Miller, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Tocilizumab is the first listed.

NCT01696929 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01696929 about?

NCT01696929 is a clinical study titled "An Open-Label Trial of Tocilizumab in Schizophrenia". This study is a Phase 1 clinical trail to determine the safety, tolerability, and efficacy of Tocilizumab (Actemra) as an adjunct to antipsychotic medications in stable outpatients with schizophrenia. Tocilizumab (structural formula C6428H9976N1720O2018S42) is a recombinant humanized anti-human inte...

What is the current status of trial NCT01696929?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-09. Estimated completion is 2014-12.

What conditions does trial NCT01696929 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01696929?

The interventions under investigation include: Tocilizumab (DRUG).

Who is sponsoring clinical trial NCT01696929?

This trial is sponsored by Brian Miller, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01696929 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.