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

Phase 4

Terminated

• Conditions: Haloperidol Causing Adverse Effects in Therapeutic Use; Loxapine Causing Adverse Effects in Therapeutic Use; Agitation,Psychomotor; Lorazepam Causing Adverse Effects in Therapeutic Use
• Interventions: Drug: Loxapine; Drug: Haloperidol + lorazepam

• Registration Number: NCT03110900
• Lead Sponsor: University of Arkansas

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-09-30
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-04
• Results First Submitted: 2018-04-09
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Results First Posted: 2018-06-11
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loxapine	Loxapine	Inhaled loxapine 10mg + IM normal saline
haloperidol + lorazepam	Haloperidol + lorazepam	IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States