Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

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: NCT02525991
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Brief Summary:
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.

Condition or disease Intervention/treatment Phase
Agitation Device: Staccato® Delivery System Loxapine (ADASUVE®) Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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®.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 18-65 years, inclusive
  2. Patients (or legal representative) willing and able to provide written Informed Consent Form.
  3. 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.
  4. 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.
  5. 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)
  6. 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).
  7. 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).
  8. Availability of patient's medical records data about the previous treatment with ADASUVE® at hospital setting.
  9. 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.

Exclusion Criteria:

  1. Patient diagnosed with dementia.
  2. 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).
  3. Patients with a history of allergic reactions to loxapine or amoxapine
  4. Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.
  5. Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Spain
Ferrer Internacional S.A.
Barcelona, Spain, 08028
Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
Layout table for investigator information
Study Director: Thais B Teixeira, PharmD, PhD Ferrer Internacional SA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT02525991    
Other Study ID Numbers: FER-Loxapine-2015-01
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Keywords provided by Ferrer Internacional S.A.:
schizophrenia
bipolar disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Loxapine
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