A Study of Staccato Loxapine (ADASUVE®) for Inhalation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-08-01

Brief Summary

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

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Detailed Description

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This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of Staccato Loxapine or placebo in treating acute agitation in patients with schizophrenia or bipolar disorder (manic or mixed episodes) as defined by DSM-V criteria.Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Conditions

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Psychomotor Agitation Schizophrenia Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled loxapine

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

Group Type EXPERIMENTAL

Inhaled loxapine

Intervention Type DRUG

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

Inhaled placebo

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

Group Type PLACEBO_COMPARATOR

Inhaled placebo

Intervention Type DRUG

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

Interventions

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Inhaled loxapine

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

Intervention Type DRUG

Inhaled placebo

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

Intervention Type DRUG

Other Intervention Names

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ADASUVE

Eligibility Criteria

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Inclusion Criteria

* 1\. Male and female patients between the ages of 18 to 65 years, inclusive.
* 2\. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder.
* 3\. 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.
* 4\. Patients are judged to be cooperative by the Investigator.
* 5\. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained.

Exclusion Criteria

* 1\. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment).
* 2\. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
* 3\. Patients with a history of allergy or intolerance to loxapine or amoxapine.
* 4\. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding.
* 5\. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
* 6\. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No