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

NCT03110900 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 206292
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

haloperidol + lorazepam

ACTIVE COMPARATOR

IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler

Drug: Haloperidol + lorazepam

loxapine

EXPERIMENTAL

Inhaled loxapine 10mg + IM normal saline

Drug: Loxapine

Interventions

Haloperidol + lorazepam DRUG

Haloperidol + lorazepam + placebo

Also known as: Haldol + Ativan

haloperidol + lorazepam

Loxapine DRUG

loxapine + placebo

Also known as: Adasuve

loxapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead
• Mount Sinai Hospital, Chicago: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Haloperidol; Lorazepam; Loxapine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzoxazepines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Michael Wilson, M.D.
• Organization: University of Arkansas for Medical Sciences

mpwilso1@outlook.com

(501) 686-5515

Study Officials

• Michael P Wilson, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 12, 2017
• Study Start: September 30, 2017
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: June 11, 2018
• Results First Posted: June 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)