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Trial record 1 of 1 for:    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
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A Study of Staccato Loxapine (ADASUVE®) for Inhalation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148963
Recruitment Status : Unknown
Verified January 2019 by Lee's Pharmaceutical Limited.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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

Condition or disease Intervention/treatment Phase
Psychomotor Agitation Schizophrenia Bipolar Disorder Drug: Inhaled loxapine Drug: Inhaled placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhaled loxapine
Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
Drug: Inhaled loxapine
Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
Other Name: ADASUVE

Placebo Comparator: Inhaled placebo
Inhaled placebo, may repeat x 1 or 2 after 2 hours
Drug: Inhaled placebo
Inhaled placebo, may repeat x 1 or 2 after 2 hours




Primary Outcome Measures :
  1. Change in PANSS-EC From Baseline [ Time Frame: 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 Outcome Measures :
  1. Change in PANSS-EC From Baseline [ Time Frame: Baseline and 30 minutes ]
  2. Change in PANSS-EC From Baseline [ Time Frame: Baseline and 4 hours ]
  3. Change in PANSS-EC From Baseline [ Time Frame: Baseline and 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04148963    
Other Study ID Numbers: ADS-ZK-2019
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee's Pharmaceutical Limited:
schizophrenia
bipolar disorder
agitation
inhaled loxapine
ADASUVE
Additional relevant MeSH terms:
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Psychomotor Agitation
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Nervous System Diseases
Psychomotor Disorders
Loxapine
Dyskinesias
Neurologic Manifestations
Neurobehavioral Manifestations
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action