Back to resultsInhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (loxapine)
Primary Purpose
Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Haloperidol + lorazepam
Loxapine
Sponsored by
About this trial
This is an interventional treatment trial for Agitation,Psychomotor
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
haloperidol + lorazepam
loxapine
Arm Description
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Inhaled loxapine 10mg + IM normal saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03110900
First Posted
March 16, 2017
Last Updated
May 11, 2018
Sponsor
University of Arkansas
Collaborators
Mount Sinai Hospital, Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03110900
Brief Title
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Withdrawal
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Mount Sinai Hospital, Chicago
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
haloperidol + lorazepam
Arm Type
Active Comparator
Arm Description
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Arm Title
loxapine
Arm Type
Experimental
Arm Description
Inhaled loxapine 10mg + IM normal saline
Intervention Type
Drug
Intervention Name(s)
Haloperidol + lorazepam
Other Intervention Name(s)
Haldol + Ativan
Intervention Description
Haloperidol + lorazepam + placebo
Intervention Type
Drug
Intervention Name(s)
Loxapine
Other Intervention Name(s)
Adasuve
Intervention Description
loxapine + placebo
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)
Description
Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Wilson, MD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
We'll reach out to this number within 24 hrs