A Study of Staccato Loxapine (ADASUVE®) for Inhalation

NCT04148963 | Unknown Phase 3 FDA Drug

• 1 other identifier: ADS-ZK-2019
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.

Conditions

Psychomotor Agitation; Schizophrenia; Bipolar Disorder

Keywords

schizophrenia; bipolar disorder; agitation; inhaled loxapine; ADASUVE

Outcome Measures

Primary Outcomes (1)

• Change in PANSS-EC From Baseline

  The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.

  Time Frame: Baseline and 2 hours

Secondary Outcomes (3)

• Change in PANSS-EC From Baseline

  Baseline and 30 minutes

• Change in PANSS-EC From Baseline

  Baseline and 4 hours

• Change in PANSS-EC From Baseline

  Baseline and 24 hours

Study Arms (2)

Inhaled loxapine

EXPERIMENTAL

Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours

Drug: Inhaled loxapine

Inhaled placebo

PLACEBO COMPARATOR

Inhaled placebo, may repeat x 1 or 2 after 2 hours

Drug: Inhaled placebo

Interventions

Inhaled loxapine DRUG

Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours

Also known as: ADASUVE

Inhaled loxapine

Inhaled placebo DRUG

Inhaled placebo, may repeat x 1 or 2 after 2 hours

Inhaled placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male and female patients between the ages of 18 to 65 years, inclusive.
• \. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder.
• \. Patients are judged to be clinical mild to moderate agitation at baseline with a total value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of ≥3 on CGI-S scale.
• \. Patients are judged to be cooperative by the Investigator.
• \. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained.

You may not qualify if:

• \. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment).
• \. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
• \. Patients with a history of allergy or intolerance to loxapine or amoxapine.
• \. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding.
• \. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
• \. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia; Bipolar Disorder

Interventions

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; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Dibenzoxazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: December 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-01