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

Agitation,Psychomotor Clinical Trial

— loxapine  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03110900
• Other study ID #: 206292
• Status: Terminated
• Phase: Phase 4
• Start date: September 30, 2017
• Est. completion date: April 4, 2018

Study information

• Verified date: May 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 4, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Haloperidol Causing Adverse Effects in Therapeutic Use
• Lorazepam Causing Adverse Effects in Therapeutic Use
• Loxapine Causing Adverse Effects in Therapeutic Use
• Psychomotor Agitation

Intervention

Drug:
• Haloperidol + lorazepam
Haloperidol + lorazepam + placebo
• Loxapine
loxapine + placebo

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Mount Sinai Hospital, Chicago

Country where clinical trial is conducted

United States, 

Outcome

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