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A Study of Staccato Loxapine (ADASUVE®) for Inhalation

Primary Purpose

Psychomotor Agitation, Schizophrenia, Bipolar Disorder

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Inhaled loxapine

Inhaled placebo

About this trial

This is an interventional treatment trial for Psychomotor Agitation focused on measuring schizophrenia, bipolar disorder, agitation, inhaled loxapine, ADASUVE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled loxapine

Inhaled placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in PANSS-EC From Baseline

Full Information

NCT ID

NCT04148963

First Posted

October 31, 2019

Last Updated

November 4, 2019

Sponsor

Lee's Pharmaceutical Limited

1. Study Identification

Unique Protocol Identification Number

NCT04148963

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

May 1, 2020 (Anticipated)

Study Completion Date

August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lee's Pharmaceutical Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychomotor Agitation, Schizophrenia, Bipolar Disorder

Keywords

schizophrenia, bipolar disorder, agitation, inhaled loxapine, ADASUVE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inhaled loxapine

Arm Type

Experimental

Arm Description

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

Arm Title

Inhaled placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled loxapine

Other Intervention Name(s)

ADASUVE

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in PANSS-EC From Baseline

Description

Time Frame

Time Frame: Baseline and 2 hours

Secondary Outcome Measure Information:

Title

Change in PANSS-EC From Baseline

Time Frame

Baseline and 30 minutes

Title

Change in PANSS-EC From Baseline

Time Frame

Baseline and 4 hours

Title

Change in PANSS-EC From Baseline

Time Frame

Baseline and 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

A Study of Staccato Loxapine (ADASUVE®) for Inhalation

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