Clinical trial NCT04148963: A Study of Staccato Loxapine (ADASUVE®) for Inhalation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psychomotor Agitation
Schizophrenia
Bipolar Disorder
Keywords: schizophrenia
bipolar disorder
agitation
inhaled loxapine
ADASUVE
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PANSS-EC From Baseline
timeFrame: Time Frame: Baseline and 2 hours
Secondary outcomes:
measure: Change in PANSS-EC From Baseline
timeFrame: Baseline and 30 minutes
measure: Change in PANSS-EC From Baseline
timeFrame: Baseline and 4 hours
measure: Change in PANSS-EC From Baseline
timeFrame: Baseline and 24 hours
Other outcomes:
Locations:
Study officials:
References: