A Study of Staccato Loxapine (ADASUVE®) for Inhalation

NCT04148963 — Phase 3, Unknown, 150 participants, Lee's Pharmaceutical Limited

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A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder

Registry	NCT04148963
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	150 (Estimated)
Sponsor	Lee's Pharmaceutical Limited (Industry)
Conditions	Psychomotor Agitation, Schizophrenia, Bipolar Disorder
Interventions	Inhaled loxapine, Inhaled placebo (Drug)
Dates	start 2019-12-01 (estimated), primary completion 2020-05-01 (estimated), completion 2020-08-01 (estimated), first posted 2019-11-04, last updated 2019-11-05

-Summary

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

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.

+Arms and interventions

Arm	Type	Interventions	Description
Inhaled loxapine	Experimental	Drug: Inhaled loxapine	Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
Inhaled placebo	Placebo comparator	Drug: Inhaled placebo	Inhaled placebo, may repeat x 1 or 2 after 2 hours

Inhaled loxapine (Drug), also known as ADASUVE: Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
Inhaled placebo (Drug): Inhaled placebo, may repeat x 1 or 2 after 2 hours

+Outcome measures

Primary outcomes

Change in PANSS-EC From Baseline [Time Frame: Baseline and 2 hours]: 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.

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.