Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
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|ClinicalTrials.gov Identifier: NCT02525991|
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : November 4, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Agitation||Device: Staccato® Delivery System Loxapine (ADASUVE®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||323 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intervention: treatment with Loxapine staccato- just one treatment arm - outside the hospital setting.|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of Self-administered ADASUVE® (Staccato Loxapine for Inhalation) in Agitated Patients Outside the Hospital Setting|
|Actual Study Start Date :||September 8, 2016|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Staccato® Delivery System Loxapine
Staccato® Delivery System Loxapine, 9.1 mg one dose
Device: Staccato® Delivery System Loxapine (ADASUVE®)
one dose Loxapine Staccato 9.1 mg
Other Name: ADASUVE®
- Serious adverse events and adverse events of special interest ( respiratory) [ Time Frame: one year ]To assess the safety profile of self-administered ADASUVE® outside the hospital setting in a population of patients that are known ADASUVE® responders and well trained on the use of the product, with a primary focus on serious adverse events (SAEs) and adverse events of special interest (AESI) related to ADASUVE®, including respiratory events
- time to improvement of the agitation episode after the self-administration of ADASUVE® outside the hospital setting. [ Time Frame: one year ]To evaluate the time to improvement of the agitation episode after the self-adminsitration of ADASUVE® outside the hospital setting.
- Prevalence of the medication for treating agitation episode in the hospital setting after self-administration of ADASUVE®. [ Time Frame: one year ]To determine the prevalence of the medication treatment for an agitation episode in the hospital setting after self-administration of ADASUVE®.
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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|
- Male and female patients between the ages of 18-65 years, inclusive
- Patients (or legal representative) willing and able to provide written Informed Consent Form.
- Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.
- Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.
- Previously treated with ADASUVE® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
- Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).
- Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
- Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.
- If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.
- Patient diagnosed with dementia.
- Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis).
- Patients with a history of allergic reactions to loxapine or amoxapine
- Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
- Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525991
|Ferrer Internacional S.A.|
|Barcelona, Spain, 08028|
|Study Director:||Thais B Teixeira, PharmD, PhD||Ferrer Internacional SA|
|Responsible Party:||Ferrer Internacional S.A.|
|Other Study ID Numbers:||
|First Posted:||August 18, 2015 Key Record Dates|
|Last Update Posted:||November 4, 2020|
|Last Verified:||November 2020|
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action