Agitation,PsychomotorPhase 4loxapineNCT03110900
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
A Phase 4 study testing Haloperidol + lorazepam and Loxapine in people with Agitation,Psychomotor and Haloperidol Causing Adverse Effects in Therapeutic Use, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Haloperidol + lorazepam and Loxapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 4 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
Read the 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.
- Conditions
- Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use
- Being tested
- Haloperidol + lorazepam, Loxapine
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol + lorazepamDrug
Also called Haldol + Ativan
Haloperidol + lorazepam + placebo
LoxapineDrug
Also called Adasuve
loxapine + placebo
| Study group | Role | What they receive |
|---|---|---|
| haloperidol + lorazepam | Active comparator | IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler Receives: Drug: Haloperidol + lorazepam |
| loxapine | Experimental | Inhaled loxapine 10mg + IM normal saline Receives: Drug: Loxapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start30 Sep 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Why it stopped: Sponsor Withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Agitation,PsychomotorStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Chicago
- Responsible party
- Sponsor
- Investigators
- Michael P Wilson, MD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110900
- Sponsor's protocol ID
- 206292
- Acronym
- loxapine
- Status last verified
- May 2018
- First submitted
- 16 Mar 2017
- Last updated
- 11 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation
- ClinicalTrials.gov ID
- NCT03110900
- Acronym / sponsor ID
- loxapine / 206292
- Conditions
- Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Withdrawal
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Chicago
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| haloperidol + lorazepam | Active comparator | Drug: Haloperidol + lorazepamIM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler |
| loxapine | Experimental | Drug: LoxapineInhaled loxapine 10mg + IM normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol + lorazepamAlso: Haldol + AtivanHaloperidol + lorazepam + placebo | Drug | haloperidol + lorazepam |
| LoxapineAlso: Adasuveloxapine + placebo | Drug | loxapine |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Wilson, MD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol + lorazepam and Loxapine in people with Agitation,Psychomotor and Haloperidol Causing Adverse Effects in Therapeutic Use, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.