Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (loxapine)

May 11, 2018 updated by: University of Arkansas

A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation

The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Requires treatment for agitation in the judgment of a physician
  2. Patient either pre-consented, has surrogate consent, or able to consent (in cases of mild agitation).
  3. The patient is at least 18 years of age and less than 65 years of age.
  4. Patients with known or presumed schizophrenia or bipolar 1 disorder.

Exclusion Criteria:

  1. Patients with acute respiratory signs/symptoms (eg, wheezing).
  2. Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking meds for asthma or COPD.
  3. Female patients who are obviously pregnant or breast-feeding.
  4. Medically unstable patients.
  5. Patients or surrogates who object to being in the study (even if previously pre-consented).
  6. Physician objection to patient enrollment in the study.
  7. Prisoners or incarcerated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: haloperidol + lorazepam
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Drug: Haloperidol + lorazepam
Haloperidol + lorazepam + placebo
Other Names:
  • Haldol + Ativan
EXPERIMENTAL: loxapine
Inhaled loxapine 10mg + IM normal saline
Drug: Loxapine
loxapine + placebo
Other Names:
  • Adasuve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)
Time Frame: 120 minutes
Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

Mount Sinai Hospital, Chicago

Investigators

  • Principal Investigator: Michael P Wilson, MD, UAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2017

Primary Completion (ACTUAL)

April 4, 2018

Study Completion (ACTUAL)

April 4, 2018

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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